Mindful After Cancer Program for Breast Cancer Survivors

(MAC Trial)

Not yet recruiting at 2 trial locations

Overseen By Jessica Gorman, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Oregon State University

Disqualifiers: Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Mindful After Cancer (MAC) to assist breast cancer survivors with sexual and body image concerns. The program provides mindfulness training and educational materials about sexual health through online sessions with a coach. Researchers aim to assess participant recruitment, engagement with the program, and the training of professionals to deliver it. Eligible participants should be breast or gynecologic cancer survivors with ongoing sexual concerns and have access to high-speed internet. Participants will either join the 8-week program or receive educational materials after completing surveys.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to experience this innovative program.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on mindfulness and educational support, so it's unlikely that medication changes are required.

What prior data suggests that the Mindful After Cancer Program is safe for breast cancer survivors?

Research has shown that mindfulness-based programs are generally safe for breast cancer survivors. These programs can help reduce anxiety and depression and improve overall quality of life. Participants often feel better after completing them.

One study found that mindfulness-based stress reduction helped with anxiety and depression. Another study showed that participants enjoyed the program and felt less stressed. Importantly, these studies did not find any serious side effects or safety issues, suggesting that the Mindful After Cancer Program is likely safe and well-tolerated.

As the Mindful After Cancer Program continues to be researched, the main goal is to understand its safety and how participants respond to it. So far, mindfulness programs like this one have been shown to be safe for breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindful After Cancer Program because it offers a unique approach to supporting breast cancer survivors. Unlike traditional treatments that primarily focus on physical recovery, this program emphasizes mental well-being through mindfulness practices. This innovative approach is designed to help survivors manage stress, improve emotional health, and enhance overall quality of life. By integrating mindfulness techniques, the program aims to address the psychological challenges that often accompany cancer recovery, providing a holistic complement to the usual care.

What evidence suggests that the Mindful After Cancer Program might be an effective treatment for breast cancer survivors?

Research has shown that mindfulness programs can help breast cancer survivors. Studies have found that these programs reduce anxiety and depression and improve quality of life. For example, patients who participated in a mindfulness program reported feeling less stressed and more comfortable with their thinking abilities. Other findings suggest that these programs lessen symptoms and boost overall health and well-being, especially for those with high stress levels. In this trial, participants in the intervention arm will receive the Mindful After Cancer Program, which could effectively address sexual and body image concerns for breast cancer survivors. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for breast and gynecologic cancer survivors dealing with sexual health or body image concerns post-treatment. Participants must be willing to engage in an 8-week mindfulness program via videoconference, complete online surveys, and possibly participate in a one-on-one interview.

Inclusion Criteria

I was diagnosed over 6 months ago.

Access to high speed internet via smart phone, tablet, and/or computer

I am 18 years old or older.

Exclusion Criteria

I understand English, as the program is only in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the 8-week MAC program delivered by a trained mindfulness coach using videoconference and online materials

8 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for outcomes such as sexual function, anxiety, and quality of life up to 3 months post-intervention

14 weeks

3 online surveys

What Are the Treatments Tested in This Trial?

Interventions

• Mindful After Cancer Program

Trial Overview The study tests the Mindful After Cancer (MAC) Program's effectiveness on sexual health and body image among cancer survivors. It involves mindfulness training, educational content, and support delivered virtually over eight weeks by trained professionals.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Oregon State University

Lead Sponsor

Trials

51

Recruited

8,300+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7092531/

A mindfulness-based intervention for breast cancer ... Patients in the MBI group showed significant improvement on perceived cognitive impairment compared to the TAU control group with a large within-group effect ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0272735824001260

Positive health outcomes of mindfulness-based ... Taken together, significant effects of MBIs were found for several positive outcomes in cancer patients and survivors, with the strongest evidence found for ...

3. jmir.org jmir.org/2022/11/e40059/

Effect of a 4-Week Internet-Delivered Mindfulness-Based ... Conclusions: Our preliminary findings suggest that the iMBCR program effectively improved the symptom burden and HRQoL of patients with breast ...

4. ascopubs.org ascopubs.org/doi/abs/10.1200/OP.23.00617

Moderators of Intervention Efficacy in the Pathways to ... Our 6-week, group-based SE program may be most beneficial for women with higher levels of psychological distress and those who feel least prepared for cancer ...

5. bmcpsychology.biomedcentral.com bmcpsychology.biomedcentral.com/articles/10.1186/s40359-024-02092-y

The use of mindfulness-based stress reduction (MBSR) for ... This study showed significant improvements in anxiety, depression, and QOL in breast cancer patients after MBSR, and the improvements persisted ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11041535/

Implementation of a Mindful Walking Intervention in Breast ... The research results on walking as well as on mindfulness-based interventions in BC patients illustrate the effectiveness and relevance of both ...

7. cancer.jmir.org cancer.jmir.org/2022/1/e31756

Evaluation of the Pathways for Survivors Program to Address ... Conclusions: The Pathways for Survivors program was favorably received. Anxiety and depression decreased significantly at 1- and 6-weeks after ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/0284186X.2017.1342862

Mindfulness-based interventions for women with breast ... The primary outcome was health-related quality of life. Secondary outcomes were fatigue, sleep stress, depression, anxiety, and safety.

9. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03025139?term=ganz&recrs=a&cond=breast+cancer&rank=1

Mindfulness Meditation or Survivorship Education in ... Survivorship education after treatment may reduce stress and improve the well-being and quality of life of patients with breast cancer. Mindfulness ...