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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03233334
Enrollment
15
Registered
2017-07-28
Start date
2017-08-01
Completion date
2019-01-31
Last updated
2019-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

BEHAVIORALPurpose Project

The purpose project intervention 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 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 life that helps them flourish.

Sponsors

Allina Health System
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 74 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in psychological well-beingWill 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

MeasureTime frameDescription
RecruitmentUp to 1 month after IRB approvalNumber 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 pre-testing sessionDuration of pre-testing session (approximately 2 hours) at week 0 to week 1Actual length (in minutes) of pre-testing session.
Time of testing sessionEach week from week 2 through week 8, approximately 2.5 hours at each sessionActual length (in minutes) of testing session.
Time of post-testing sessionDuration of session 8 (at week 12), approximately 2 hoursActual length (in minutes) of testing session.
Homework completionEach week from week 2 through week 8Whether or not homework was attempted
Purpose Status and ExpectationsAt Week 12A 2-question self-report developed by the study team to better understand what participants' hope to gain during the study and perceived changes.
Change in Meaning in lifeAt week 0 and at week 12Meaning 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).
Change in Satisfaction with Participation in Discretionary Social ActivitiesAt week 0 and at week 12Satisfaction 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).
Engagement in Meaningful ActivitiesAt week 0 and at week 12Engagement 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.
Participant Experience of Purpose ProjectAt week 12 and at week 14-20Participant experience of purpose project as measured by self-report questionnaire and post-intervention interview.
Intervention fidelityEach week from week 2 through week 8Which key intervention elements were provided during a given session

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026