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Completed

NCT Number: NCT03233334

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 25 and 74 years of age
  • Completed chemotherapy and/or radiation treatment for Stage 1, 2, or 3 breast cancer up to 5 years prior to study enrollment
  • English speaking
  • Graduated from high school
  • Able to see, hear, speak (with or without assistive devices)
  • Able to provide own transportation to sessions
  • 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

  • Stage 4 breast cancer or any other stage 4 cancer
  • Actively receiving chemotherapy or radiation treatments for cancer. (However, patients may be on Herceptin and/or endocrine treatment and participate in the study.)
  • History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning
  • Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.

Treatment and study plan

Purpose Project

Behavioral

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.

Primary outcomes

  1. Change in psychological well-being

    Time frame: 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 outcomes

  1. Recruitment

    Time frame: 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

  2. Time of pre-testing session

    Time frame: Duration of pre-testing session (approximately 2 hours) at week 0 to week 1

    Actual length (in minutes) of pre-testing session.

  3. Time of testing session

    Time frame: Each week from week 2 through week 8, approximately 2.5 hours at each session

    Actual length (in minutes) of testing session.

  4. Time of post-testing session

    Time frame: Duration of session 8 (at week 12), approximately 2 hours

    Actual length (in minutes) of testing session.

  5. Homework completion

    Time frame: Each week from week 2 through week 8

    Whether or not homework was attempted

  6. Intervention fidelity

    Time frame: Each week from week 2 through week 8

    Which key intervention elements were provided during a given session

  7. Change in Meaning in life

    Time frame: 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).

  8. Change in Satisfaction with Participation in Discretionary Social Activities

    Time frame: 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).

  9. Engagement in Meaningful Activities

    Time frame: 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.

  10. Purpose Status and Expectations

    Time frame: 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.

  11. Participant Experience of Purpose Project

    Time frame: At week 12 and at week 14-20

    Participant experience of purpose project as measured by self-report questionnaire and post-intervention interview.

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 28, 2017
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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