Compass Course: Efficacy Study

NCT03442686 | Completed

• 1 other identifier: CKMW-1801
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

Brief Summary

The Compass Course is an 8-session progressive structure that was developed based on theoretical and scientific evidence from psychology and occupational therapy. The goal of the intervention is to provide participants with information, tools, and support that help them move towards reclaiming a sense of self-grounded purpose in daily life. The study will use a convenience sample of breast cancer survivors to evaluate the efficacy of the Compass Course intervention.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in psychological well-being

  Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, \& Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.

  Will be administered at Week 0 (pre-testing), at Week 12 (session 8), and at 3 month follow up

Secondary Outcomes (10)

• Recruitment

  Up to 1 month after IRB approval

• Time of pre-testing session

  Duration of pre-testing session (approximately 2 hours) at week 0 to week 1

• Time of testing session

  Each week from week 2 through week 8, approximately 2 hours at each session

• Time of post-testing session

  Duration of session 8 (at week 12), approximately 1 hour

• Homework completion

  Each week from week 2 through week 8

Study Arms (2)

Spring 2018 Compass Course Group

EXPERIMENTAL

Two groups of up to 15 participants (30 total) will receive the study intervention during Spring 2018. All participants will complete study questionnaires before and after the Spring sessions.

Behavioral: Compass Course

Spring 2018 Comparison Group

NO INTERVENTION

Two groups of up to 15 participants will receive the study intervention in Fall 2018. All participants will complete study questionnaires before and after the Spring sessions. Those who enroll in the study and agree to participate in the Fall sessions will serve as a no-treatment comparison group.

Interventions

Compass Course BEHAVIORAL

An 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention, called the Compass Course is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in their daily lives.

Spring 2018 Compass Course Group

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Completed treatment (such as chemotherapy, radiation, surgery) for Stage 0, 1, 2, or 3 breast cancer at least 2 months prior to participating in the Compass Course intervention
• English speaking
• High school diploma or GED
• Able to see, hear, speak (with or without assistive devices)
• Able to provide own transportation to sessions
• Willing and able to commit to attend all 8 intervention sessions

You may not qualify if:

• Stage 4 breast cancer or any other stage 4 cancer
• Actively receiving chemotherapy or radiation treatments for cancer. (However, patients may be on Herceptin and/or endocrine treatment and participate in the study.)
• History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning
• Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (3)

Courage Kenny Rehabilitation Institute

Golden Valley, Minnesota, 55422, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Allina Health Shoreview Clinic

Shoreview, Minnesota, 55126, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mary Radomski, PhD, OTR/L

  Allina Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientific Advisor

Model Details: This study uses a wait list control design. One group of participants will be evaluated before receiving the intervention (in Spring 2018) and compared to those who receive the intervention in Spring 2018. The first group will go on to receive the intervention in Fall 2018.

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: March 2, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 12, 2021

Record last verified: 2021-05

Locations

US (3)