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Completed

NCT Number: NCT04559854

Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer

The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (Mindful After Cancer, MAC) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and gynecologic cancer survivors.

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon State University

Corvallis, Oregon, 97331, United States

About this study

The specific aims are: 1) Assess the feasibility of the MAC program when delivered via videoconference and 2) Assess preliminary effects of the the program.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of breast or gynecologic cancer at least one year prior to enrollment
  • Completed primary cancer treatment
  • English speaking
  • Have access to a computer, smart phone, or tablet with internet access
  • Ability to spend 15-30 minutes per day on program activities

Exclusion criteria

  • Stage 0 (carcinoma in situ)

Treatment and study plan

Mindful After Cancer

Behavioral

The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions.

Primary outcomes

  1. Feasibility/ Enrollment in the Study

    Time frame: Baseline (T1)

    Percentage of participants enrolled of those eligible

  2. Feasibility/ Retention in the Study

    Time frame: 1 month post-intervention (T2)

    Number and percentage of participants completing all assessments

  3. Feasibility/ Retention in the Intervention

    Time frame: 1 month post-intervention (T2)

    Number and percentage attending at least 6 of 8 sessions

  4. Acceptability of the Intervention

    Time frame: 1 month post-intervention (T2)

    Endorsement of 10 items characterizing acceptability of the intervention (e.g., the program met my expectations). Range 10-100. Higher score indicates better acceptability.

Secondary outcomes

  1. Change From Baseline Interest in Sexual Activity at 1 Month

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

    PROMIS Sexual Function and Satisfaction 2.0. 2 items. Range 2-10. Higher score indicates more interest in sexual activity.

  2. Change From Baseline Satisfaction With Sex Life at 1 Month

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

    New Sexual Satisfaction Scale- Short Form (NSSS-S). 12 items. Range 12-60. Higher score indicates more sexual satisfaction.

  3. Change From Baseline Self-efficacy at 1 Month

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

    Self-efficacy for Managing Chronic Disease Scale (adapted). 6 items. Range 6-60. Higher score indicates better self-efficacy for managing sexual health after cancer.

  4. Change From Baseline Body Image at 1 Month

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

    Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image.

  5. Change From Baseline Body Appreciation at 1 Month

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

    Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation.

  6. Change From Baseline Anxiety at 1 Month

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

    PROMIS Emotional Distress Anxiety Short Form 6a. 6 items. Range 6-30. Higher score indicates greater anxiety symptoms.

  7. Change From Baseline Depression at 1 Month

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

    Center for Epidemiologic Studies Depression Scale (CES-D). 20 items. Range 0-60. Higher score indicates greater depressive symptoms

  8. Change in Facets of Baseline Mindfulness at 1 Month

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

    Five-Facet Mindfulness Questionnaire (FFMQ-15). 15 items with 5 sub-scales: Observe, Describe; Act with Awareness; Non-Judgement, Non-Reactivity. Sub-scale score range 3-15. Higher score indicates greater mindfulness.

  9. Change From Baseline Self-compassion at 1 Month

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

    Self-Compassion Scale short form. 12 items. Total score is calculated based on mean of item responses (each item ranges 1-5). Higher mean score indicates greater self-compassion.

  10. Change From Baseline Relationship Quality at 1 Month

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

    Dyadic Adjustment Scale short form (DAS-7). Range 0-36. Higher score indicates more positive relationship quality

Sponsors and collaborators

Lead sponsor

Oregon State University

Other

Collaborators

  • OHSU Knight Cancer Institute

Registry information

Official study title

Mindful After Cancer Study: Fostering Positive Body Image, Sexual Health, and Well-being

Acronym: MAC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2020
Registry last updated
Jun 25, 2025

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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