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A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors

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ClinicalTrials.gov Identifier: NCT03768336
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Giselle K. Perez Lougee, Massachusetts General Hospital

Brief Summary:
This research study aims to explore the feasibility and acceptability of an adapted resiliency group program, called the Relaxation Response Resiliency Program (3RP-AYA), to reduce stress and promote stress-management among adolescents and young adults who have completed treatment for cancer.

Condition or disease Intervention/treatment Phase
Cancer Other: Waitlist control Other: 3RP-AYA Not Applicable

Detailed Description:

The Relaxation Response Resiliency Program, or 3RP, was developed by researchers at the MGH Benson-Henry Institute for Mind Body Medicine. The 3RP is a group program that—through a variety of mind-body approaches, such as imagery, relaxation, and yoga—seeks to buffer stress and promote psychological resiliency and physical well-being.

The 3RP has not yet been carried out with adolescent or young adult individuals who have recently completed treatment for cancer. As such, the investigators have adapted the original 3RP to target the specific needs of adolescent and young adult patients who are transitioning off active treatment. The investigators are conducting this study to see if the adapted program, the 3RP-AYA, is effective at reducing stress and stress-related symptoms for people of at least age 16 who have completed treatment for cancer within the past five years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Stress Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Active Comparator: Waitlist Control
  • The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions
  • Mini relaxation practice
  • Weekly goal check-ins
  • RR-practice
Other: Waitlist control
The 3RP is a group program that—through a variety of mind-body approaches, such as imagery, relaxation, and yoga—seeks to buffer stress and promote psychological resiliency and physical well-being. Waitlist control receives the adapted 3RP program (3RP-AYA) approximately 2 months after study enrollment.

Experimental: 3RP Group Sessions
  • The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions
  • Mini relaxation practice
  • Weekly goal check-ins
  • RR-practice
Other: 3RP-AYA
The 3RP is a group program that—through a variety of mind-body approaches, such as imagery, relaxation, and yoga—seeks to buffer stress and promote psychological resiliency and physical well-being.




Primary Outcome Measures :
  1. 3RP-AYA Feasibility: Percent of identified eligibles who enroll [ Time Frame: Post-treatment completion (approximately 8 weeks) ]
    Percent of identified eligibles who enroll. Attendance to the session will also be considered as a component of feasibility

  2. 3RP-AYA Acceptability: five questions [ Time Frame: Post-treatment completion (approximately 8 weeks) ]
    Acceptability will be assessed with five questions rated on a 5-point Likert scale (1=not at all to 5=very much). Items will prompt participants to rate the extent to which they found the program to be enjoyable, helpful, applicable, convenient, and if they are likely to use strategies in the future.



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Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with any cancer between ages 15 and 27
  • Completed cancer treatment within the past 5 years
  • At least 16 years of age at time of enrollment

Exclusion Criteria:

  • Unwilling or unable to participate in the study
  • Unable to speak or read English
  • Is medically or otherwise unable to participate (as determined by a physician or study PI)
  • Unwilling or unable to participate in study sessions delivered via the Partners Telehealth videoconferencing software
  • Participation in a focus group during Phase 1 (DF/HCC 17-315)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768336


Contacts
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Contact: Giselle K. Perez, PhD 617-724-4000 Gperez@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02214
Contact: Giselle K. Perez, PhD    617-724-4000    gperez@mgh.harvard.edu   
Principal Investigator: Giselle K. Perez, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Giselle K. Perez, PhD Massachusetts General Hospital

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Responsible Party: Giselle K. Perez Lougee, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03768336     History of Changes
Other Study ID Numbers: 18-428
1K07CA211955-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Giselle K. Perez Lougee, Massachusetts General Hospital:
Cancer
Behavioral Intervention
Adolescent
Young Adult