Clinical trial NCT03233334: Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)
Official title: Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 15
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in psychological well-being
timeFrame: Will be administered at Week 0 (pre-testing) and at Week 12 (session 8).
Secondary outcomes:
measure: Recruitment
timeFrame: Up to 1 month after IRB approval
measure: Time of pre-testing session
timeFrame: Duration of pre-testing session (approximately 2 hours) at week 0 to week 1
measure: Time of testing session
timeFrame: Each week from week 2 through week 8, approximately 2.5 hours at each session
measure: Time of post-testing session
timeFrame: Duration of session 8 (at week 12), approximately 2 hours
measure: Homework completion
timeFrame: Each week from week 2 through week 8
measure: Intervention fidelity
timeFrame: Each week from week 2 through week 8
measure: Change in Meaning in life
timeFrame: At week 0 and at week 12
measure: Change in Satisfaction with Participation in Discretionary Social Activities
timeFrame: At week 0 and at week 12
measure: Engagement in Meaningful Activities
timeFrame: At week 0 and at week 12
measure: Purpose Status and Expectations
timeFrame: At Week 12
measure: Participant Experience of Purpose Project
timeFrame: At week 12 and at week 14-20
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Allina Health
name: Mary Radomski, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: