Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Purpose Project

• Registration Number: NCT03233334
• Lead Sponsor: Allina Health System

Brief Summary

The Purpose Project intervention 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 women with breast cancer to evaluate the feasibility of the Purpose Project intervention in terms of demand/acceptability, implementation, and limited-efficacy testing. Findings will be used to inform a later study to evaluate the efficacy of the Purpose Project intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-28
• Study Start: 2017-08-01
• Primary Completion: 2018-08-01
• Study Completion: 2019-01-31
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

1. Between 25 and 74 years of age
2. Completed chemotherapy and/or radiation treatment for Stage 1, 2, or 3 breast cancer up to 5 years prior to study enrollment
3. English speaking
4. Graduated from high school
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, 2 testing sessions, and the one-to-one interview that occurs after completing the 8 intervention sessions.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Purpose Project Group	Purpose Project	Group receiving Purpose Project intervention.

Primary Outcome Measures

Name	Time	Method
Change in psychological well-being	Will be administered at Week 0 (pre-testing) and at Week 12 (session 8).	Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, \& Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.

Secondary Outcome Measures

Name	Time	Method
Recruitment	Up to 1 month after IRB approval	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 of testing session	Each week from week 2 through week 8, approximately 2.5 hours at each session	Actual length (in minutes) of testing session.
Participant Experience of Purpose Project	At week 12 and at week 14-20	Participant experience of purpose project as measured by self-report questionnaire and post-intervention interview.
Intervention fidelity	Each week from week 2 through week 8	Which key intervention elements were provided during a given session
Time of pre-testing session	Duration of pre-testing session (approximately 2 hours) at week 0 to week 1	Actual length (in minutes) of pre-testing session.
Time of post-testing session	Duration of session 8 (at week 12), approximately 2 hours	Actual length (in minutes) of testing session.
Change in Satisfaction with Participation in Discretionary Social Activities	At week 0 and at week 12	Satisfaction with Participation in Discretionary Social Activities (Hahn et al., 2010): Self-report questionnaires in which participants rated their level of satisfaction (1-5 scale) with social roles (14 items) and discretionary activities (12 items).
Homework completion	Each week from week 2 through week 8	Whether or not homework was attempted
Change in Meaning in life	At week 0 and at week 12	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).
Engagement in Meaningful Activities	At week 0 and at week 12	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.
Purpose Status and Expectations	At Week 12	A 2-question self-report developed by the study team to better understand what participants' hope to gain during the study and perceived changes.

Trial Locations

Locations (1)

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States