Ignite Creation Date:
2024-07-17 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461416
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-10
Brief Title:
A Trial for a Preliminary Estimate of the Effectiveness of a Novel Theoretical Framework
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
Occupational Resilience A Pilot Trial for a Preliminary Estimate of the Effectiveness of a Novel Theoretical Framework
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim 1 To determine the preliminary effect sizes of al ActiveHeal EST Engage-Sustain-Triumph Program on occupational resilience
Aim 2 To determine the preliminary effect sizes of ActiveHeal EST Engage-Sustain-Triumph on health status quality of life QoL and Psychological wellbeing PWB
Aim 3 To determine the extent to which ActiveHeal EST Engage-Sustain-Triumph Program is an acceptable and feasible Intervention for breast and prostate cancer survivors
Aim 2 To determine the preliminary effect sizes of ActiveHeal EST Engage-Sustain-Triumph on health status quality of life QoL and Psychological wellbeing PWB
Aim 3 To determine the extent to which ActiveHeal EST Engage-Sustain-Triumph Program is an acceptable and feasible Intervention for breast and prostate cancer survivors
Detailed Description:
The study will utilize the randomized study design with two groups of 20 participants each arm The intervention group will receive occupational therapy services for 12 weeks The control group will meet three times via zoom but not receive an intervention All participants will have three assessments completed before and after the intervention The experimental group will have a feasibility and acceptability survey at the end of the intervention
Week 1-6 Recruitment Informed Consent Process Commenced and Randomization Both Groups A B Week 7-8 Pretests Administer Occupational Resilience Measure ORM 10 World Health Organization Quality of Life Scale WHOQOL BREF and Psychological Wellbeing Scale To be completed with participant via Zoom Both Groups A B Week 9 1113 15 17 19 Week 1 3 5 7 9 11 of the ActiveHeal EST Engage-Sustain-TriumphProgram Six Group ActiveHeal EST Sessions Group A only Each session is 75 minutes It will include education on benefits of activity and strategies to make sustained performance possible highlighting History Experience Benefits and Adaptation Location UAMS Northwest Campus The group sessions will be led by the PI or one of the trained occupational therapists who are familiar with the applied group and individual therapy process and a student assistant to assist in the specified group activity performance Although the intervention approach is specific the use of activity as intervention is well understood by any certified occupational therapist The training will therefore focus on what the sessions look like if these four factors are the guide to group or individual intervention Four additional therapists will be trained by PI in a 60 minute group session to be able lead individual or group sessions
ActiveHeal EST Engage-Sustain-Triumph group sessions will utilize a developmental group intervention model Such intervention models allow the group to increasingly take charge of group activities and processes with more structure and support at the beginning but members gradually take over leadership and group management roles ideally running the group and meeting shared goals without a therapist by the end of the process This model is selected because it has potential to enable members to develop relationships and build capacities that allow them to support one another after the intervention period The model is also selected to allow participants to draw from benefits of group interventions including installation of hope universality imparting of knowledge altruism corrective family re-enactment development of socialization skills imitative behavior interpersonal learning group cohesiveness catharsis and finding meaning
Because these models are known to be optimal with 5-10 participants Group A participants will be divided into two groups but the same session plan will be used on the day of the meetings That is there will be two similar sessions per day of meeting and participants will attend one session with the same group each time Group members will vote for their preferred activities for the upcoming meeting and the activities that are favored by the majority will be selected if consistent with group goals These activities may include group physical exercise healthy meal preparation activity meditation yoga guided imagery music experience listening andor performance and dance
All ActiveHeal EST Engage-Sustain-Triumph sessions will follow Coles 7 steps which are Introduction Activity Sharing Processing Generalizing Application and Summary These 7 steps will allow participants contemplate and share their experiences with a particular activity History demonstrate or build capacity for activity performance Experience reflect on health benefits of an activity Benefits and consider ways to sustain activity when barriers emerge adaptation The 7 steps ensure that in each session group members will 1 undertake an activity as a group 2 reflect or share how they have or could apply this activity to support health and 3 develop a feasible plan for its application while keeping in mind possible barriers and potential solutions to optimize activity engagement
Each ActiveHeal EST Engage-Sustain-Triumph session will include a blend of 1 educational content and 2 an activity for each session used to facilitate learning Tentatively the session themes include
Everyday enjoyment of music Adaptation - What if I cant do it today Developing and sustaining habits Therapeutic use of arts and crafts Applying meditation practices Making healthy eating a habit
Session themes about content will be retained regardless of the kind of activities selected by group members but activities will be determined in consultation with group members consistent with commonly accepted group intervention guidelines
Educational content will consistently highlight the impact of History Experience Benefits and Adaptation on long-term activity performance and strategies for promoting success in enduring activity performance Regardless of the activity selected four OR factors will be covered within Coles last 3 steps led by an occupational therapist and an assistant
Week 11 14 Week 3 and 6 of active study period Control Group B Meeting via Zoom - this study meeting lasts 15 to 30 minutes allowing the PI to touch base with the control participants to see how they are doing This meeting is not intended to be therapeutic or interventional
Week 10 12 14 16 18 20 Week 2 4 6 8 10 12 of the ActiveHeal EST Engage-Sustain-Triumph Program Six Individualized ActiveHeal EST Engage-Sustain-Triumph Sessions Group A only Each participant in the experiment group will receive 6 occupational therapy visits at their home or other selected location This session will focus on the activities that the participants selected at the start of the program Using the methods covered in group sessions to strengthen activity performance with individualized occupational therapy intervention added All interventions will focus on building History Experience Benefits and Adaptation More focus may be given to any of the four based on a participants strengths and weaknesses at the discretion of treating therapist All four factors must be addressed and documented per visit
Week 17 Week 9 of active study period Control Group B Meeting via Zoom - this study meeting lasts 15 to 30 minutes allowing the PI to touch base with the control participants to see how they are doing This meeting is not intended to be therapeutic or interventional
Week 21-22 Posttests - Re-administer Occupational Resilience Measure ORM 10 World Health Organization Quality of Life Scale WHOQOL BREF and Psychological Wellbeing Scale To be completed with participant via Zoom Both Groups A B Group A will additionally complete Acceptability of Intervention Measure AIM and Feasibility of Intervention Measure FIM
Week 1-6 Recruitment Informed Consent Process Commenced and Randomization Both Groups A B Week 7-8 Pretests Administer Occupational Resilience Measure ORM 10 World Health Organization Quality of Life Scale WHOQOL BREF and Psychological Wellbeing Scale To be completed with participant via Zoom Both Groups A B Week 9 1113 15 17 19 Week 1 3 5 7 9 11 of the ActiveHeal EST Engage-Sustain-TriumphProgram Six Group ActiveHeal EST Sessions Group A only Each session is 75 minutes It will include education on benefits of activity and strategies to make sustained performance possible highlighting History Experience Benefits and Adaptation Location UAMS Northwest Campus The group sessions will be led by the PI or one of the trained occupational therapists who are familiar with the applied group and individual therapy process and a student assistant to assist in the specified group activity performance Although the intervention approach is specific the use of activity as intervention is well understood by any certified occupational therapist The training will therefore focus on what the sessions look like if these four factors are the guide to group or individual intervention Four additional therapists will be trained by PI in a 60 minute group session to be able lead individual or group sessions
ActiveHeal EST Engage-Sustain-Triumph group sessions will utilize a developmental group intervention model Such intervention models allow the group to increasingly take charge of group activities and processes with more structure and support at the beginning but members gradually take over leadership and group management roles ideally running the group and meeting shared goals without a therapist by the end of the process This model is selected because it has potential to enable members to develop relationships and build capacities that allow them to support one another after the intervention period The model is also selected to allow participants to draw from benefits of group interventions including installation of hope universality imparting of knowledge altruism corrective family re-enactment development of socialization skills imitative behavior interpersonal learning group cohesiveness catharsis and finding meaning
Because these models are known to be optimal with 5-10 participants Group A participants will be divided into two groups but the same session plan will be used on the day of the meetings That is there will be two similar sessions per day of meeting and participants will attend one session with the same group each time Group members will vote for their preferred activities for the upcoming meeting and the activities that are favored by the majority will be selected if consistent with group goals These activities may include group physical exercise healthy meal preparation activity meditation yoga guided imagery music experience listening andor performance and dance
All ActiveHeal EST Engage-Sustain-Triumph sessions will follow Coles 7 steps which are Introduction Activity Sharing Processing Generalizing Application and Summary These 7 steps will allow participants contemplate and share their experiences with a particular activity History demonstrate or build capacity for activity performance Experience reflect on health benefits of an activity Benefits and consider ways to sustain activity when barriers emerge adaptation The 7 steps ensure that in each session group members will 1 undertake an activity as a group 2 reflect or share how they have or could apply this activity to support health and 3 develop a feasible plan for its application while keeping in mind possible barriers and potential solutions to optimize activity engagement
Each ActiveHeal EST Engage-Sustain-Triumph session will include a blend of 1 educational content and 2 an activity for each session used to facilitate learning Tentatively the session themes include
Everyday enjoyment of music Adaptation - What if I cant do it today Developing and sustaining habits Therapeutic use of arts and crafts Applying meditation practices Making healthy eating a habit
Session themes about content will be retained regardless of the kind of activities selected by group members but activities will be determined in consultation with group members consistent with commonly accepted group intervention guidelines
Educational content will consistently highlight the impact of History Experience Benefits and Adaptation on long-term activity performance and strategies for promoting success in enduring activity performance Regardless of the activity selected four OR factors will be covered within Coles last 3 steps led by an occupational therapist and an assistant
Week 11 14 Week 3 and 6 of active study period Control Group B Meeting via Zoom - this study meeting lasts 15 to 30 minutes allowing the PI to touch base with the control participants to see how they are doing This meeting is not intended to be therapeutic or interventional
Week 10 12 14 16 18 20 Week 2 4 6 8 10 12 of the ActiveHeal EST Engage-Sustain-Triumph Program Six Individualized ActiveHeal EST Engage-Sustain-Triumph Sessions Group A only Each participant in the experiment group will receive 6 occupational therapy visits at their home or other selected location This session will focus on the activities that the participants selected at the start of the program Using the methods covered in group sessions to strengthen activity performance with individualized occupational therapy intervention added All interventions will focus on building History Experience Benefits and Adaptation More focus may be given to any of the four based on a participants strengths and weaknesses at the discretion of treating therapist All four factors must be addressed and documented per visit
Week 17 Week 9 of active study period Control Group B Meeting via Zoom - this study meeting lasts 15 to 30 minutes allowing the PI to touch base with the control participants to see how they are doing This meeting is not intended to be therapeutic or interventional
Week 21-22 Posttests - Re-administer Occupational Resilience Measure ORM 10 World Health Organization Quality of Life Scale WHOQOL BREF and Psychological Wellbeing Scale To be completed with participant via Zoom Both Groups A B Group A will additionally complete Acceptability of Intervention Measure AIM and Feasibility of Intervention Measure FIM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None