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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233334
• Other study ID #: CKMR-1702
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: July 2019
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 31, 2019
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Purpose 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.

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Will be administered at Week 0 (pre-testing) and at Week 12 (session 8).
Secondary	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	Up to 1 month after IRB approval
Secondary	Time of pre-testing session	Actual length (in minutes) of pre-testing session.	Duration of pre-testing session (approximately 2 hours) at week 0 to week 1
Secondary	Time of testing session	Actual length (in minutes) of testing session.	Each week from week 2 through week 8, approximately 2.5 hours at each session
Secondary	Time of post-testing session	Actual length (in minutes) of testing session.	Duration of session 8 (at week 12), approximately 2 hours
Secondary	Homework completion	Whether or not homework was attempted	Each week from week 2 through week 8
Secondary	Intervention fidelity	Which key intervention elements were provided during a given session	Each week from week 2 through week 8
Secondary	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).	At week 0 and at week 12
Secondary	Change in Satisfaction with Participation in Discretionary Social Activities	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).	At week 0 and at week 12
Secondary	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.	At week 0 and at week 12
Secondary	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.	At Week 12
Secondary	Participant Experience of Purpose Project	Participant experience of purpose project as measured by self-report questionnaire and post-intervention interview.	At week 12 and at week 14-20