Clinical trial NCT04767464: Feasibility of Providing a Purpose Renewal Intervention for Cancer Survivors Via Virtual Groups
Official title: Feasibility of Providing a Purpose Renewal Intervention for Cancer Survivors Via Virtual Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Neoplasm
Keywords: Purpose
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Compass Course (CC) is a group intervention designed for individuals with Breast Cancer. Over the course of 8 face-to-face group sessions, the CC is designed to help participants reclaim a sense of self-grounded purpose in daily life, defined as intentional use of time and energy in ways that align with one's values, strengths, and sources of personal meaning (e.g., inner compass) in the moments that compose a day. Because of COVID-19, in-person groups are discouraged and so we need to identify new ways to provide group-based interventions that are feasible and efficacious.


Eligibility criteria: Inclusion Criteria:

1. Able to attend intervention sessions for 9 weeks on Monday or Tuesday afternoons (4:30 - 6:30 pm) starting Monday, April 5, 2021
2. 25 years of age or older
3. Completed chemotherapy and/or radiation treatment for Stage 0, 1, 2, or 3 breast cancer at least 2 months prior to participating in the Compass Course intervention
4. English speaking
5. Graduated from high school
6. Able to see, hear, speak (with or without assistive devices)
7. Able to provide own transportation to sessions
8. Willing and able to commit to attend all 8 intervention sessions
9. Access to computer or tablet and adequate internet connection to participate in video conference

Exclusion Criteria:

1. Stage 4 breast cancer or any other 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.

Primary outcomes:
measure: Change in Scales of Psychological Wellbeing
timeFrame: Through Study Completion (about 4 Months)
measure: Change in Meaning in Life Questionnaire
timeFrame: Through Study Completion (about 4 Months)
measure: Change in Engagement in Meaningful Activities survey
timeFrame: Through Study Completion (about 4 Months)
measure: Change in Purpose Status Question
timeFrame: Through Study Completion (about 4 Months)
Secondary outcomes:
measure: Change in Beck Depression Inventory -- II
timeFrame: Through Study Completion (about 4 Months)
measure: Change in State-Trait Anxiety Inventory
timeFrame: Through Study Completion (about 4 Months)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Senior Scientific Advisor
name: Mary V Radomski, OTR/L, PhD
role: PRINCIPAL_INVESTIGATOR
References: