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CompletedNCT03442686Updated May 12, 2021

Compass Course: Efficacy Study

An interventional study of Compass Course in Breast Cancer, sponsored by Allina Health System. Completed at 3 sites in United States. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2021-05-12.

Sponsored by Allina Health System · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Non-randomized
Ages
25 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer
03

Who can participate

Ages eligible
25 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. 25 years of age or older
  2. 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
  3. English speaking
  4. High school diploma or GED
  5. Able to see, hear, speak (with or without assistive devices)
  6. Able to provide own transportation to sessions
  7. Willing and able to commit to attend all 8 intervention sessions

Exclusion criteria

Exclusion criteria (all self-reported):

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

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Spring 2018 Compass Course Group

    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

  • No intervention
    Spring 2018 Comparison Group

    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

  • BehavioralCompass Course

    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.

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What researchers measure

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.

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

Secondary outcomes

  1. Recruitment

    Number of prospective participants approached by clinicians and number of self-referred prospective participants who contact PI or Study Coordinator with inquiries about the study

    Time frame: Up to 1 month after IRB approval

  2. Time of pre-testing session

    Actual length (in minutes) of pre-testing session.

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

  3. Time of testing session

    Actual length (in minutes) of testing session.

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

  4. Time of post-testing session

    Actual length (in minutes) of testing session.

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

  5. Homework completion

    Whether or not homework was attempted

    Time frame: Each week from week 2 through week 8

  6. Intervention fidelity

    Which key intervention elements were provided during a given session

    Time frame: Each week from week 2 through week 8

  7. Change in Meaning in life

    Meaning in Life Questionnaire (Steger et al., 2006): A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).

    Time frame: At week 0 and at week 12, and at 3 month follow up

  8. Engagement in Meaningful Activities

    Engagement in Meaningful Activities Survey (Eakman, 2010):A 12-item self-report questionnaire designed to measure the extent to which a person experiences meaningfulness in his/her daily life activities.

    Time frame: At week 0 and at week 12

  9. Purpose Status and Expectations

    A 2-question self-report developed by the study team to better understand what participants' hope to gain during the study and perceived changes.

    Time frame: At week 0, at week 12, and at 3 month follow up

  10. Participant Experience of Compass Course

    Participant experience of Compass Course as measured by self-report questionnaire and post-intervention focus group.

    Time frame: At week 12 and at week 14-20

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Study locations

3 sites
  • Courage Kenny Rehabilitation Institute
    Golden Valley, Minnesota 55422, United States
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
  • Allina Health Shoreview Clinic
    Shoreview, Minnesota 55126, United States
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Registry details

Key details

Study ID
NCT03442686
Lead sponsor
Allina Health System
Responsible party
Mary Radomski (Senior Scientific Advisor, Allina Health System) — Principal investigator
First posted
Feb 22, 2018
Start date
Mar 2, 2018
Primary completion
May 1, 2021
Completion
May 1, 2021
Last update
May 12, 2021

Study contacts

Mary Radomski, PhD, OTR/L
principal investigator · Allina Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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