What side effects are associated with this type of intervention?

Common treatments for cancer include chemotherapy, radiation therapy, surgery, and targeted therapy. Chemotherapy can cause side effects such as fatigue, nausea, vomiting, hair loss, and increased risk of infection. Radiation therapy may lead to skin irritation, fatigue, and localized pain. Surgery can result in pain, infection, and fatigue. Targeted therapy often causes fewer side effects but can still include fatigue, skin problems, and gastrointestinal issues. Digital health interventions, which focus on promoting well-being and teaching coping skills, aim to mitigate some of these side effects by improving mental health and quality of life.

What prior FDA approvals exist?

The FDA has approved various treatments for cancer, including targeted therapies like Dabrafenib and Trametinib for tumors with BRAFV600E mutations, as seen in the NCI-MATCH trial. While these approvals focus on the biological aspects of cancer treatment, digital health interventions, such as the one being studied in the trial for promoting well-being and teaching coping skills, aim to address the psychological and emotional needs of cancer survivors. These interventions are designed to improve quality of life by enhancing mood management and healthy coping mechanisms, complementing the medical treatments approved by the FDA.

What other types of research exist?

Promising alternatives to digital health interventions for cancer patients include: 1) Positive Affect Skills Interventions (e.g., LILAC program) which can be delivered in-person or online, 2) Cognitive Behavioral Therapy (CBT) for insomnia and mood management, available both face-to-face and online, 3) Mindfulness and Meditation Practices, such as Mindfulness-Based Stress Reduction (MBSR), and 4) Integrative Therapies like biofeedback-assisted relaxation and neurofeedback for pain and symptom management. These approaches offer various delivery methods to accommodate patient needs and preferences.

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EMPOWER Intervention for Young Adult Cancer Survivors (MOST EMPOWER Trial)

N/A

Waitlist Available

Led By John M Salsman, Ph.D

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Past history of a cancer diagnosis (excluding basal cell skin carcinoma)

15 to 39 years of age at diagnosis of first cancer and currently between the ages of 15 to 39

Must not have

Currently receiving palliative or hospice care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 4 months after intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the EMPOWER Intervention, a digital program for young adult cancer survivors. It aims to improve their well-being by teaching skills for positive thinking, mindfulness, and goal-setting. The goal is to help them feel better and manage their emotions after cancer treatment.

Who is the study for?

This trial is for young adult cancer survivors, aged 15-39, who were diagnosed with their first cancer at the same age range and are within 0-5 years post-active treatment. Participants must understand English and have internet access. Those hospitalized for psychiatric illness or in palliative/hospice care cannot join.

What is being tested?

The EMPOWER digital health intervention is being tested to see if it can improve well-being, coping skills, and mood management among young adult cancer survivors. The study aims to enhance overall wellness and quality of life through this online program.

What are the potential side effects?

Since EMPOWER is a digital health intervention focusing on emotional regulation rather than medication or medical procedures, traditional physical side effects are not expected. However, participants may experience emotional discomfort while engaging with the content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had cancer before, but not skin cancer.

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I was diagnosed with my first cancer between 15 and 39 years old and am currently in that age range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently receiving care to ease symptoms, not cure my disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 4 months after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 4 months after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 4 months after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire

Secondary study objectives

Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Questionnaire

Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire

Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

32Treatment groups

Experimental Treatment

Group I: Condition 9Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Financial Literacy and 5) Sun Protection

Group II: Condition 8Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group III: Condition 7Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Sun Protection

Group IV: Condition 6Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness

Group V: Condition 5Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Group VI: Condition 4Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group VII: Condition 32Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group VIII: Condition 31Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Sun Protection

Group IX: Condition 30Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness

Group X: Condition 3Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection

Group XI: Condition 29Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Group XII: Condition 28Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Weight Management, 4) Strengths/Achievable Goals and 5) Acts of Kindness

Group XIII: Condition 27Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection

Group XIV: Condition 26Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness

Group XV: Condition 25Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group XVI: Condition 24Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group XVII: Condition 23Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Group XVIII: Condition 22Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness

Group XIX: Condition 21Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Group XX: Condition 20Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group XXI: Condition 2Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness

Group XXII: Condition 19Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection

Group XXIII: Condition 18Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness

Group XXIV: Condition 17Experimental Treatment1 Intervention

1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Sun Protection

Group XXV: Condition 16Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group XXVI: Condition 15Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Sun Protection

Group XXVII: Condition 14Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness

Group XXVIII: Condition 13Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Group XXIX: Condition 12Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group XXX: Condition 11Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection

Group XXXI: Condition 10Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness

Group XXXII: Condition 1Experimental Treatment1 Intervention

1) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Sun Protection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EMPOWER

2022

N/A

~100

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include chemotherapy, radiation therapy, surgery, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells. Radiation therapy uses high-energy particles to damage the DNA of cancer cells, leading to cell death. Surgery physically removes tumors from the body. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Targeted therapy blocks specific molecules involved in cancer cell growth and survival. Understanding these mechanisms is crucial for cancer patients as it helps them comprehend how treatments work, manage expectations, and make informed decisions about their care. Digital health interventions that promote well-being and teach coping skills can complement these treatments by addressing the psychological and emotional challenges associated with cancer, thereby improving overall quality of life.

Electronic Health Interventions for Patients With Breast Cancer: Systematic Review and Meta-Analyses.Comparison of the acceptability and benefits of two mindfulness-based interventions in women with breast or gynecologic cancer: a pilot study.