Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-02-24 @ 10:56 AM
Study NCT ID:
NCT05235750
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2022-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'MBai@uams.edu', 'phone': '501-603-1900', 'title': 'Dr. Mei Bai', 'organization': 'University of Arkansas for Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Eight weeks following baseline data collection.', 'eventGroups': [{'id': 'EG000', 'title': 'Writing', 'description': 'This is a single-group study with one arm only.\n\nSelf-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Writing', 'description': 'This is a single-group study with one arm only.\n\nSelf-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer'}], 'classes': [{'title': 'RSES at T1', 'categories': [{'measurements': [{'value': '23.4', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'RSES at T2', 'categories': [{'measurements': [{'value': '23.5', 'spread': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'RSES at T3', 'categories': [{'measurements': [{'value': '23.7', 'spread': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'RSES at T4', 'categories': [{'measurements': [{'value': '24.2', 'spread': '4.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.83', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for RSES.', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for RSES.', 'groupDescription': 'We analyzed short- (at 6 weeks post-baseline or T3) and longer-term differences (at 8 weeks post-baseline or T4) for the RSES, expecting a larger size of differences at T3. The short-term difference \\[(T3-T2)-(T2-T1)\\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \\[(T4-T2)-(T2-T1)\\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.91', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.2', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for RSES.', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for RSES.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)', 'description': 'Changes include raw score changes and standardized mean differences. Scores on the Rosenberg Self-esteem Scale range from 0 to 30, with higher score indicating higher level of self-esteem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Writing', 'description': 'This is a single-group study with one arm only.\n\nSelf-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer'}], 'classes': [{'title': 'FACT-G (total score) at T1', 'categories': [{'measurements': [{'value': '78.7', 'spread': '15.2', 'groupId': 'OG000'}]}]}, {'title': 'FACT-G (total score) at T2', 'categories': [{'measurements': [{'value': '80.7', 'spread': '16.3', 'groupId': 'OG000'}]}]}, {'title': 'FACT-G (total score) at T3', 'categories': [{'measurements': [{'value': '80.7', 'spread': '14.9', 'groupId': 'OG000'}]}]}, {'title': 'FACT-G (total score) at T4', 'categories': [{'measurements': [{'value': '81.2', 'spread': '17.0', 'groupId': 'OG000'}]}]}, {'title': 'PWB at T1', 'categories': [{'measurements': [{'value': '20.6', 'spread': '4.8', 'groupId': 'OG000'}]}]}, {'title': 'PWB at T2', 'categories': [{'measurements': [{'value': '19.4', 'spread': '6.0', 'groupId': 'OG000'}]}]}, {'title': 'PWB at T3', 'categories': [{'measurements': [{'value': '19.3', 'spread': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'PWB at T4', 'categories': [{'measurements': [{'value': '19.5', 'spread': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'SWB at T1', 'categories': [{'measurements': [{'value': '22.7', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'SWB at T2', 'categories': [{'measurements': [{'value': '24.1', 'spread': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'SWB at T3', 'categories': [{'measurements': [{'value': '23.5', 'spread': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'SWB at T4', 'categories': [{'measurements': [{'value': '23.6', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'EWB at T1', 'categories': [{'measurements': [{'value': '18.6', 'spread': '3.9', 'groupId': 'OG000'}]}]}, {'title': 'EWB at T2', 'categories': [{'measurements': [{'value': '19.1', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'EWB at T3', 'categories': [{'measurements': [{'value': '19.3', 'spread': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'EWB at T4', 'categories': [{'measurements': [{'value': '19.5', 'spread': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'FWB at T1', 'categories': [{'measurements': [{'value': '16.8', 'spread': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'FWB at T2', 'categories': [{'measurements': [{'value': '18.1', 'spread': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'FWB at T3', 'categories': [{'measurements': [{'value': '18.7', 'spread': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'FWB at T4', 'categories': [{'measurements': [{'value': '18.5', 'spread': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Gf7 at T1', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Gf7 at T2', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Gf7 at T3', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Gf7 at T4', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Ge6 at T1', 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Ge6 at T2', 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Ge6 at T3', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Ge6 at T4', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.45', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.1', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for the total FACT-G.', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for the total FACT-G.', 'groupDescription': 'We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACT-G at scale, factor and item levels expecting a larger size of differences at T3. The short-term difference \\[(T3-T2)-(T2-T1)\\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \\[(T4-T2)-(T2-T1)\\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.29', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.3', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for the total FACT-G.', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for the total FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.46', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.8', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for physical well-being (PWB) as measured by the FACT-G.', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for physical well-being (PWB) as measured by the FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.79', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for physical well-being (PWB) as measured by the FACT-G.', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for physical well-being (PWB) as measured by the FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.05', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.1', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for social/family well-being (SWB) as measured by the FACT-G.', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for social/family well-being (SWB) as measured by the FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.03', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.4', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for social/family well-being (SWB) as measured by the FACT-G.', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for social/family well-being (SWB) as measured by the FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.82', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.2', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for emotional well-being (EWB) as measured by the FACT-G.', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for emotional well-being (EWB) as measured by the FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.58', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.5', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for emotional well-being (EWB) as measured by the FACT-G.', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for emotional well-being (EWB) as measured by the FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.56', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.8', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for functional well-being (FWB) as measured by the FACT-G.', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for functional well-being (FWB) as measured by the FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.58', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.7', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for functional well-being (FWB) as measured by the FACT-G.', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for functional well-being (FWB) as measured by the FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.58', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.2', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for Global QoL (item G7 "I am content with the quality of my life right now") as measured by the FACT-G.', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for Global QoL (item G7 "I am content with the quality of my life right now") as measured by the FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.34', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.3', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\] for Global QoL (item G7 "I am content with the quality of my life right now") as measured by the FACT-G.', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for Global QoL (item G7 "I am content with the quality of my life right now") as measured by the FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.27', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.4', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for item Ge6 "I worry that my condition will get worse" as measured by the FACT-G.', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for item Ge6 "I worry that my condition will get worse" as measured by the FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.62', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for item Ge6 "I worry that my condition will get worse" as measured by the FACT-G.', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for item Ge6 "I worry that my condition will get worse" as measured by the FACT-G.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)', 'description': 'Changes include raw score changes and standardized mean differences. Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) range from 0 to 108, with higher score indicating higher level of quality of life. Each subscale ranging from 0 to 28, with higher score indicating higher level of quality of life. The raw scores of overall QoL (total FACT-G), four composite domains (physical well-being, PWB; social/family well-being, SWB; emotional well-being, EWB; functional well-being, FWB), global QoL (item Gf7 "I am content with the quality of my life right now") and one item pertinent to this study (Ge6 "I worry that my condition will get worse") were presented below.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Writing', 'description': 'This is a single-group study with one arm only.\n\nSelf-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer'}], 'classes': [{'title': 'FACIT-Sp-12 (total) at T1', 'categories': [{'measurements': [{'value': '39.5', 'spread': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'FACIT-Sp-12 (total) at T2', 'categories': [{'measurements': [{'value': '40.5', 'spread': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'FACIT-Sp-12 (total) at T3', 'categories': [{'measurements': [{'value': '41.0', 'spread': '7.0', 'groupId': 'OG000'}]}]}, {'title': 'FACIT-Sp-12 (total) at T4', 'categories': [{'measurements': [{'value': '40.0', 'spread': '8.0', 'groupId': 'OG000'}]}]}, {'title': 'M/P at T1', 'categories': [{'measurements': [{'value': '26.6', 'spread': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'M/P at T2', 'categories': [{'measurements': [{'value': '27.2', 'spread': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'M/P at T3', 'categories': [{'measurements': [{'value': '26.9', 'spread': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'M/P at T4', 'categories': [{'measurements': [{'value': '26.8', 'spread': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'Faith at T1', 'categories': [{'measurements': [{'value': '12.9', 'spread': '3.9', 'groupId': 'OG000'}]}]}, {'title': 'Faith at T2', 'categories': [{'measurements': [{'value': '13.2', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Faith at T3', 'categories': [{'measurements': [{'value': '14.1', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Faith at T4', 'categories': [{'measurements': [{'value': '13.2', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Faith (revised) at T1', 'categories': [{'measurements': [{'value': '13.2', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Faith (revised) at T2', 'categories': [{'measurements': [{'value': '13.7', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Faith (revised) at T3', 'categories': [{'measurements': [{'value': '14.1', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Faith (revised) at T4', 'categories': [{'measurements': [{'value': '13.5', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'FACIT-Sp-12 total (revised) at T1', 'categories': [{'measurements': [{'value': '39.8', 'spread': '7.7', 'groupId': 'OG000'}]}]}, {'title': 'FACIT-Sp-12 total (revised) at T2', 'categories': [{'measurements': [{'value': '40.9', 'spread': '6.6', 'groupId': 'OG000'}]}]}, {'title': 'FACIT-Sp-12 total (revised) at T3', 'categories': [{'measurements': [{'value': '40.9', 'spread': '6.9', 'groupId': 'OG000'}]}]}, {'title': 'FACIT-Sp-12 total (revised) at T4', 'categories': [{'measurements': [{'value': '39.8', 'spread': '8.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.76', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.6', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for the total FACIT-Sp-12.', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for the total FACIT-Sp-12.', 'groupDescription': 'We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACIT-Sp-12 at scale and factor levels, expecting a larger size of differences at T3. The short-term difference \\[(T3-T2)-(T2-T1)\\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \\[(T4-T2)-(T2-T1)\\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.19', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.1', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for the total FACIT-Sp-12.', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for the total FACIT-Sp-12.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.35', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.0', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.99', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.9', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.46', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.4', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for the Faith factor of the FACIT-Sp-12.', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for the Faith factor of the FACIT-Sp-12.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.24', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.7', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for the Faith factor of the FACIT-Sp-12.', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for the Faith factor of the FACIT-Sp-12.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.55', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.4', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for the revised Faith factor of the FACIT-Sp-12.', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for the revised Faith factor of the FACIT-Sp-12.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.80', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.9', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for the revised Faith factor of the FACIT-Sp-12.', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for the revised Faith factor of the FACIT-Sp-12.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.34', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.5', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for the total FACIT-Sp-12 (revised).', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for the total FACIT-Sp-12 (revised).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.91', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.0', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for the total FACIT-Sp-12 (revised).', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for the total FACIT-Sp-12 (revised).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)', 'description': "Changes include raw score changes and standardized mean differences. The FACIT-Sp-12 scale measures an individual's level of spiritual well-being, specifically assessing their sense of meaning, peace, and faith in life, with higher scores indicating a better level of spiritual well-being and lower scores a worse level of spiritual well-being. It consists of 12 items rated on a 5-point Likert scale (0 = Not at all to 4 = Very much). The FACIT-Sp-12 Scale consists of 2 sub-scales Meaning/Peace (M/P) with a range of 0-32, and Faith ranging from 1-16. Possible overall spiritual well-being or FACIT-Sp-12 (total) range from 0 to 48. The revised Faith subscale as well as the revised FACIT-Sp-12 scale have the same scale range of the original measures.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Writing', 'description': 'This is a single-group study with one arm only.\n\nSelf-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer'}], 'classes': [{'title': 'HADS-A at T1', 'categories': [{'measurements': [{'value': '6.6', 'spread': '3.9', 'groupId': 'OG000'}]}]}, {'title': 'HADS-A at T2', 'categories': [{'measurements': [{'value': '5.4', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'HADS-A at T3', 'categories': [{'measurements': [{'value': '5.7', 'spread': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'HADS-A at T4', 'categories': [{'measurements': [{'value': '5.3', 'spread': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'HADS-D at T1', 'categories': [{'measurements': [{'value': '4.7', 'spread': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'HADS-D at T2', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'HADS-D at T3', 'categories': [{'measurements': [{'value': '4.2', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'HADS-D at T4', 'categories': [{'measurements': [{'value': '4.5', 'spread': '3.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.14', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.1', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for HADS-anxiety subscale (HADS-A).', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for HADS-anxiety subscale (HADS-A).', 'groupDescription': 'We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for two subscales HADS-A and HADS-D respectively, expecting a larger size of differences at T3. The short-term difference \\[(T3-T2)-(T2-T1)\\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \\[(T4-T2)-(T2-T1)\\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.14', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.2', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for HADS-anxiety subscale (HADS-A).', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for HADS-anxiety subscale (HADS-A).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.32', 'groupIds': ['OG000'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.6', 'pValueComment': 'The above p value refers to the difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for HADS-depression subscale (HADS-D).', 'estimateComment': 'The above value represents net difference between post-intervention change and pre-intervention change (or \\[(T3-T2)-(T2-T1)\\]) for HADS-depression subscale (HADS-D).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '.20', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.9', 'pValueComment': 'The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for HADS-depression subscale (HADS-D).', 'estimateComment': 'The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \\[(T4-T2)-(T2-T1)\\]) for HADS-depression subscale (HADS-D).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)', 'description': 'Changes include raw score changes and standardized mean differences. Scores on the Hospital Anxiety and Depression Scale (HADS) range from 0 to 42, with higher score indicating higher level of anxiety or depression. The two subscales HADS anxiety (HADS-A) and HADS depression (HADS-D) were analyzed separately. Each sub-scale has a range from 0-21, with the higher score indicating higher level of anxiety or depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Writing', 'description': 'This is a single-group study with one arm only.\n\nSelf-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Writing', 'description': 'This is a single-group study with one arm only.\n\nSelf-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '9.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'non-Hispanic', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Up to 8th grade', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'High school', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'College', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Graduate school', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital status', 'classes': [{'categories': [{'title': 'single', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'married', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'divorced', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'widowed', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Religious affiliation', 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Protestant', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Catholic', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Undisclosed', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time since cancer diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '23.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stage of cancer', 'classes': [{'categories': [{'title': 'III', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'IV', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'recurrent', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'unstaged', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer site', 'classes': [{'categories': [{'title': 'Gastrointestinal (GI)', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Lung', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Gynecological (GYN)', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Head and neck', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Prostate', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Breast', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Hematological', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preference to talk', 'classes': [{'categories': [{'title': 'yes', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'no', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'not sure', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ever wrote a diary in life', 'classes': [{'categories': [{'title': 'no', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'yes', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Should one have a religious affiliation to be spiritual?', 'classes': [{'categories': [{'title': 'no', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'yes', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Perceived threat from cancer diagnosis', 'classes': [{'categories': [{'title': 'a great deal threatening', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'moderately threatening', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'a little threatening', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'not or hardly threatening', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Two patients were deceased shortly after enrollment and one was unable to reach again, leaving a total of 54 participants who were able to complete baseline data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-27', 'size': 765006, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-04T19:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2022-02-01', 'resultsFirstSubmitDate': '2024-07-07', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-07', 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline', 'timeFrame': 'Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)', 'description': 'Changes include raw score changes and standardized mean differences. Scores on the Rosenberg Self-esteem Scale range from 0 to 30, with higher score indicating higher level of self-esteem.'}, {'measure': 'Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline', 'timeFrame': 'Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)', 'description': 'Changes include raw score changes and standardized mean differences. Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) range from 0 to 108, with higher score indicating higher level of quality of life. Each subscale ranging from 0 to 28, with higher score indicating higher level of quality of life. The raw scores of overall QoL (total FACT-G), four composite domains (physical well-being, PWB; social/family well-being, SWB; emotional well-being, EWB; functional well-being, FWB), global QoL (item Gf7 "I am content with the quality of my life right now") and one item pertinent to this study (Ge6 "I worry that my condition will get worse") were presented below.'}], 'secondaryOutcomes': [{'measure': 'Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline', 'timeFrame': 'Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)', 'description': "Changes include raw score changes and standardized mean differences. The FACIT-Sp-12 scale measures an individual's level of spiritual well-being, specifically assessing their sense of meaning, peace, and faith in life, with higher scores indicating a better level of spiritual well-being and lower scores a worse level of spiritual well-being. It consists of 12 items rated on a 5-point Likert scale (0 = Not at all to 4 = Very much). The FACIT-Sp-12 Scale consists of 2 sub-scales Meaning/Peace (M/P) with a range of 0-32, and Faith ranging from 1-16. Possible overall spiritual well-being or FACIT-Sp-12 (total) range from 0 to 48. The revised Faith subscale as well as the revised FACIT-Sp-12 scale have the same scale range of the original measures."}, {'measure': 'Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline', 'timeFrame': 'Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)', 'description': 'Changes include raw score changes and standardized mean differences. Scores on the Hospital Anxiety and Depression Scale (HADS) range from 0 to 42, with higher score indicating higher level of anxiety or depression. The two subscales HADS anxiety (HADS-A) and HADS depression (HADS-D) were analyzed separately. Each sub-scale has a range from 0-21, with the higher score indicating higher level of anxiety or depression.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '39812781', 'type': 'DERIVED', 'citation': 'Bai M, Cella D, Jeon S, Govindarajan R, Birrer MJ. Self-affirmation intervention for patients newly diagnosed with advanced cancer: a preliminary efficacy trial. J Psychosoc Oncol. 2025;43(4):593-615. doi: 10.1080/07347332.2025.2450013. Epub 2025 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if a brief writing intervention works to improve quality of life outcomes in adult patients newly diagnosed with advanced stage cancer.', 'detailedDescription': "A diagnosis of cancer may challenge one's former assumptions and beliefs about themselves and the world and potentially compromise quality of life (QoL). The primary aim of the study is to explore the preliminary efficacy of an intervention to protect individuals from the negative psychological impact of the cancer diagnosis. The secondary aim is to test the validity of the Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being 12 item Scale (FACIT-Sp-12), in its current and revised forms. Potential participants will be enrolled from two study sites as per protocol: the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences (UAMS) and the Arkansas Hospice respectively, and will be asked to write as guided by the researcher for 4 weeks. Study outcomes will be assessed at baseline, 2-, 6- and 8-weeks post baseline. It is hypothesized that self-affirmation via writing at the time following a diagnosis of an advanced cancer by affirming values or beliefs that are salient to self will help enhance self-esteem, reinforce spiritual well-being, decrease levels of anxiety or depression, and improve QoL."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* within 8 weeks of being informed of diagnosis (primary or recurrent)\n* cancer stage III or IV of a primary solid tumor, or a high-grade hematological malignancy, and\n* age 18 years or older\n\nExclusion Criteria:\n\n* medical condition precluding participation (e.g., too ill or fatigued, acute mental confusion as determined by the treating physician), or\n* enrolled in other psychosocial experiments'}, 'identificationModule': {'nctId': 'NCT05235750', 'briefTitle': 'Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer: A Preliminary Efficacy Trial', 'orgStudyIdInfo': {'id': '273876'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Writing', 'description': 'This is a single-group study with one arm only.', 'interventionNames': ['Behavioral: Self-affirmation writing']}], 'interventions': [{'name': 'Self-affirmation writing', 'type': 'BEHAVIORAL', 'description': 'Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer', 'armGroupLabels': ['Writing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72116', 'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Hospice', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}], 'overallOfficials': [{'name': 'Mei Bai, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}