What is the mechanism of action of this treatment?

Behavioral interventions such as social support and mindfulness training are designed to improve the quality of life and reduce symptom burden in cancer patients. Social support offers emotional and practical assistance, which can alleviate stress and enhance adherence to treatment plans. Mindfulness training helps manage anxiety, depression, and fatigue by fostering mental well-being and resilience. These approaches are essential as they address the psychological and emotional challenges of cancer, complementing traditional medical treatments and potentially improving overall patient outcomes.

What side effects are associated with this type of intervention?

Behavioral interventions such as the mHealth MVPA Intervention, which includes social support and mindfulness training, are generally safe and aim to alleviate symptoms like fatigue, depression, and anxiety without significant side effects. In contrast, traditional cancer treatments like chemotherapy can cause nausea, fatigue, hair loss, and increased risk of infection. Radiation therapy may lead to skin irritation, fatigue, and localized pain, while surgery carries risks of infection, pain, and recovery-related fatigue. Combining these approaches can help manage both the physical and psychological burdens of cancer treatment.

What prior FDA approvals exist?

FDA approvals for cancer treatments have primarily focused on pharmacological interventions, including chemotherapy, immunotherapy, and targeted therapies. However, there is growing interest in complementary approaches such as behavioral modifications, social support, and mindfulness training to improve quality of life and manage symptoms in cancer patients. While specific FDA approvals for behavioral interventions in cancer care are limited, these approaches are increasingly being integrated into comprehensive cancer treatment plans to address the psychological and physical well-being of patients.

What other types of research exist?

Promising alternatives to mHealth MVPA interventions for cancer patients include: 1) Telemedicine-based physical activity programs, which can provide remote support and monitoring. 2) Web-based platforms like My Viva Plan (MVP) that integrate mindfulness, nutrition, and physical activity. 3) Group physiotherapy programs that offer social support and structured exercise. 4) Mindfulness-Based Stress Reduction (MBSR) courses delivered via videoconferencing. 5) Yoga and mindfulness interventions tailored for cancer patients to improve quality of life and reduce symptom burden.

← Back to Search

Mobile Health & Mindfulness for Young Adult Cancer Survivors

N/A

Recruiting

Led By Siobhan M Phillips, PhD, MPH

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

For YACS: Age at diagnosis between 18-39 years and at time of screening / study overview session

Be between 18 and 65 years old

Must not have

For YACS: Diagnosis of non-melanoma skin cancer

For YACS: Inability to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a mobile health program using a Fitbit and an app to help young adult cancer survivors stay active. The program includes coaching, support from a buddy, and mindfulness exercises. It aims to improve their quality of life by increasing physical activity and reducing symptoms like fatigue and anxiety.

Who is the study for?

This trial is for young adult cancer survivors aged 18-39, who are at least three months post-primary treatment but may still be on hormone therapies. They should engage in less than 60 minutes of moderate to vigorous physical activity weekly, own a smartphone with internet access, and speak English fluently. Participants need a 'Buddy' willing to support them and share Fitbit data. Pregnant individuals or those in other trials cannot join.

What is being tested?

The OPT2MOVE study tests four components: e-coaching, buddy support, general mindfulness training, and MVPA-specific mindfulness training within a mobile health program aimed at increasing physical activity over 12 weeks among young adult cancer survivors to improve their quality of life.

What are the potential side effects?

Since this trial focuses on exercise and mindfulness training rather than medication or invasive procedures, significant side effects are not expected. However, participants might experience typical exercise-related discomforts such as muscle soreness.

Eligibility Criteria

Inclusion Criteria

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

Select...

I was diagnosed with my condition between the ages of 18 and 39.

Exclusion Criteria

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

Select...

I have been diagnosed with a type of skin cancer that is not melanoma.

Select...

I am unable to understand and give consent for treatment.

Select...

I do not have any conditions that completely prevent me from exercising, do not have cancer that has spread, and am not planning any elective surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Physical Activity before and after the 12-week technology supported physical activity interventions in young adult cancer survivors

Secondary study objectives

Ability to participate in social roles and activities in young adult cancer survivors

Acceptability of the technology supported physical activity interventions as measured by a post-intervention evaluation survey

Adherence to the OPT2MOVE app + Fitbit by young adult cancer survivors

+34 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

16Treatment groups

Experimental Treatment

Active Control

Group I: Exp Condition 1Experimental Treatment5 Interventions

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy

Group II: Exp Condition 10Active Control2 Interventions

Research participant receives the Core Intervention + General Mindfulness Training

Group III: Exp Condition 11Active Control3 Interventions

Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy

Group IV: Exp Condition 2Active Control4 Interventions

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training

Group V: Exp Condition 4Active Control2 Interventions

Research participant receives the Core Intervention + E-Coach

Group VI: Exp Condition 6Active Control3 Interventions

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training

Group VII: Exp Condition 7Active Control4 Interventions

Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy

Group VIII: Exp Condition 9Active Control3 Interventions

Research participant receives the Core Intervention + General Mindfulness Training + Buddy

Group IX: Exp Condition 12Active Control2 Interventions

Research participant receives the Core Intervention + MVPA Specific Mindfulness Training

Group X: Exp Condition 14Active Control3 Interventions

Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training

Group XI: Exp Condition 15Active Control2 Interventions

Research participant receives the Core Intervention + Buddy

Group XII: Exp Condition 16Active Control1 Intervention

Research participant receives the Core Intervention

Group XIII: Exp Condition 13Active Control4 Interventions

Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy

Group XIV: Exp Condition 3Active Control3 Interventions

Research participant receives the Core Intervention + E-Coach + Buddy

Group XV: Exp Condition 5Active Control4 Interventions

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy

Group XVI: Exp Condition 8Active Control3 Interventions

Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Buddy

2017

N/A

~3290

0 / 4Eligibility 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

Behavioral interventions such as social support and mindfulness training are designed to improve the quality of life and reduce symptom burden in cancer patients. Social support offers emotional and practical assistance, which can alleviate stress and enhance adherence to treatment plans. Mindfulness training helps manage anxiety, depression, and fatigue by fostering mental well-being and resilience. These approaches are essential as they address the psychological and emotional challenges of cancer, complementing traditional medical treatments and potentially improving overall patient outcomes.

A Smartphone App-Based Mindfulness Intervention for Cancer Survivors: Protocol for a Randomized Controlled Trial.Comparison of the acceptability and benefits of two mindfulness-based interventions in women with breast or gynecologic cancer: a pilot study.Testing the effects of treatment complications on a cognitive-behavioral intervention for reducing symptom severity.