Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-28 @ 4:57 AM
Study NCT ID:
NCT02758756
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2016-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study on Energy Therapy or Massage to Reduce Fatigue
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Pilot Study on Energy Therapy or Massage to Reduce Fatigue in Breast and Prostate Cancer Patients on Hormone Therapy
Status:
COMPLETED
Status Verified Date:
2019-07
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:
The proposed study will assess whether either massage or an Integrative Medicine practice called Reiki can alleviate fatigue in subjects receiving hormonal treatments. Reiki is classified by the National Center for Complementary and Integrative Health as a biofield/touch therapy, and Reiki practitioners believe that their gentle therapy promotes healing and well-being by unblocking and balancing energy flow and re-establishing homeostasis within the human energy field. The study is a three-arm randomized clinical trial in 99 breast and prostate cancer patients who are undergoing hormonal therapy (i.e., androgen deprivation therapy (ADT) for males or an aromatase inhibitor (AI) for females) and currently experiencing fatigue. Subjects will be studied during ten weeks of hormonal therapy with two weeks of baseline assessments followed by a four-week intervention, and a four-week post-intervention period. Arm 1: Subjects will receive two Swedish-style massages. Arm 2: Lower-dose Reiki intervention - Subjects will receive two Reiki treatments. Arm 3: Higher-dose Reiki intervention - Subjects will receive four Reiki treatments.
Detailed Description:
5.1 This will be a randomized three-arm clinical trial pilot study of an intervention examining the efficacy of either massage or Reiki in reducing fatigue associated with hormonal treatment and to determine if four Reiki treatments are more effective than two in controlling fatigue. Subjects will be studied during ten weeks of hormonal therapy with two weeks of baseline assessments followed by a four-week intervention, and a four-week post-intervention period.
5.1.1 All ancillary treatments for control of symptoms caused by the cancer or its treatment may be administered as clinically indicated.
5.1.2 The current protocol is for a pilot study designed to gather preliminary efficacy and feasibility data for the development of a planned RO1 submission. Our intention is to gather preliminary data to generate effect size estimates for power calculations for an anticipated RO1 application. We will also use this preliminary data to help us determine whether or not we should drop or modify one or more of the current study arms when designing the planned RO1 study.
5.1.3 It is preferred that the study be completed in a time-span of ten calendar weeks, however if the subject or practitioner is unable to attend an appointment during a scheduled week, that week will not count as a study week, and it will be designated a skipped week. Only two skipped weeks will be allowed, so the maximum length of the study will be twelve calendar weeks. Subjects will not complete questionnaires during skipped weeks, and skipped weeks may not be consecutive.
5.2 Consent Process and Assessment
5.2.1 After providing written informed consent (and receiving a signed copy), the subject will complete an On-Study Data Form providing demographic and clinical data. Questions concerning the subject's experience with both Reiki and massage (and related treatments) and expectations for their efficacy in relieving fatigue are also included. Subjects will also complete a quality of life (QOL) questionnaire and sleep quality (SQ) questionnaire at time of consent.
5.2.2 Subjects will be asked to completed study questionnaires at home. They will have the option of completing questionnaires via the REDCap online survey system (see Section 6.10) or on paper. If they choose to complete paper questionnaires, they will be given a packet of study questionnaires at the time of consent. The questionnaire packet will consist of seven sets of questionnaires. Each set will have the Brief Fatigue Inventory (BFI), the Insomnia Severity Index (ISI), and a Symptom Inventory. In addition, the sixth and seventh sets of questionnaires will also include the Pittsburgh Sleep Quality Inventory (PSQI) to assess SQ, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) to assess QOL, and the Profile of Mood States (POMS). If they choose to complete questionnaires via REDCap, they will be asked to complete the same questionnaires through the online survey system. Subjects electing to use REDCap will also be given one set of paper questionnaires to be used in the event that computer access is not available when needed.
5.2.3 Subjects will be asked to complete one set of questionnaires (either through REDCap or on paper) each Friday night of the 2-week baseline and the 4-week intervention period. They will be asked to complete a final set on Friday of Week 10. A set of questionnaires takes about 10-20 minutes to complete.
5.2.4 Reminder phone calls or emails will be made by study personnel each Friday to assist the subject in remembering to complete the study forms. If they have chosen to complete paper questionnaires, they will also be instructed to return them in the provided stamped, pre-addressed envelope. (Permission will be obtained to leave messages on a subject's voicemail before any messages are left.)
5.3 An optional Heart Rate Variability (HRV) assessment will be done during study weeks 2 and 7 at the PEAK Laboratory at the URMC (see Section 6.7).
5.4 An optional fasting (8-hour) blood draw will be done at the URMC to estimate cytokines (CRP, IL-6, \& TNF-α) during study weeks 2 and 7 (see Section 6.8).
5.5 Treatment Arms:
5.5.1 Subjects assigned to Arm 1 will receive two massage treatments approximately two weeks apart.
5.5.2 Subjects assigned to Arm 2 will receive two Reiki treatments approximately two weeks apart.
5.5.3 Subjects assigned to Arm 3 will receive four Reiki treatments approximately 1 week apart.
5.5.4 Scheduling arrangements will be made for the treatments prior to the initiation of the intervention.
5.5.6 Subjects will not be charged for the Reiki or massage treatments.
5.1.1 All ancillary treatments for control of symptoms caused by the cancer or its treatment may be administered as clinically indicated.
5.1.2 The current protocol is for a pilot study designed to gather preliminary efficacy and feasibility data for the development of a planned RO1 submission. Our intention is to gather preliminary data to generate effect size estimates for power calculations for an anticipated RO1 application. We will also use this preliminary data to help us determine whether or not we should drop or modify one or more of the current study arms when designing the planned RO1 study.
5.1.3 It is preferred that the study be completed in a time-span of ten calendar weeks, however if the subject or practitioner is unable to attend an appointment during a scheduled week, that week will not count as a study week, and it will be designated a skipped week. Only two skipped weeks will be allowed, so the maximum length of the study will be twelve calendar weeks. Subjects will not complete questionnaires during skipped weeks, and skipped weeks may not be consecutive.
5.2 Consent Process and Assessment
5.2.1 After providing written informed consent (and receiving a signed copy), the subject will complete an On-Study Data Form providing demographic and clinical data. Questions concerning the subject's experience with both Reiki and massage (and related treatments) and expectations for their efficacy in relieving fatigue are also included. Subjects will also complete a quality of life (QOL) questionnaire and sleep quality (SQ) questionnaire at time of consent.
5.2.2 Subjects will be asked to completed study questionnaires at home. They will have the option of completing questionnaires via the REDCap online survey system (see Section 6.10) or on paper. If they choose to complete paper questionnaires, they will be given a packet of study questionnaires at the time of consent. The questionnaire packet will consist of seven sets of questionnaires. Each set will have the Brief Fatigue Inventory (BFI), the Insomnia Severity Index (ISI), and a Symptom Inventory. In addition, the sixth and seventh sets of questionnaires will also include the Pittsburgh Sleep Quality Inventory (PSQI) to assess SQ, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) to assess QOL, and the Profile of Mood States (POMS). If they choose to complete questionnaires via REDCap, they will be asked to complete the same questionnaires through the online survey system. Subjects electing to use REDCap will also be given one set of paper questionnaires to be used in the event that computer access is not available when needed.
5.2.3 Subjects will be asked to complete one set of questionnaires (either through REDCap or on paper) each Friday night of the 2-week baseline and the 4-week intervention period. They will be asked to complete a final set on Friday of Week 10. A set of questionnaires takes about 10-20 minutes to complete.
5.2.4 Reminder phone calls or emails will be made by study personnel each Friday to assist the subject in remembering to complete the study forms. If they have chosen to complete paper questionnaires, they will also be instructed to return them in the provided stamped, pre-addressed envelope. (Permission will be obtained to leave messages on a subject's voicemail before any messages are left.)
5.3 An optional Heart Rate Variability (HRV) assessment will be done during study weeks 2 and 7 at the PEAK Laboratory at the URMC (see Section 6.7).
5.4 An optional fasting (8-hour) blood draw will be done at the URMC to estimate cytokines (CRP, IL-6, \& TNF-α) during study weeks 2 and 7 (see Section 6.8).
5.5 Treatment Arms:
5.5.1 Subjects assigned to Arm 1 will receive two massage treatments approximately two weeks apart.
5.5.2 Subjects assigned to Arm 2 will receive two Reiki treatments approximately two weeks apart.
5.5.3 Subjects assigned to Arm 3 will receive four Reiki treatments approximately 1 week apart.
5.5.4 Scheduling arrangements will be made for the treatments prior to the initiation of the intervention.
5.5.6 Subjects will not be charged for the Reiki or massage treatments.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: