Ovarian CancerBreast CancerLung CancerGastric CancerSurvivorshipEndometrial CancerHead and Neck CancersProstate CancersGeriatric OncologyMetastatic Breast CancerMetastatic Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
625 (estimated)
Sponsor
Pack Health · Industry
Who this trial is looking for
This trial is looking for adults who have completed cancer treatment. Participants will receive digital health coaching for six months and share health-related data to help improve recovery outcomes after cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with cancer.
I am within one year of completing my primary cancer treatment.
I am at least 18 years old.
I can read and understand English.
I have access to a smartphone or tablet.
I can complete follow-up assessments at scheduled times.
You may not be able to join if
I have a cognitive impairment that affects my ability to participate.
I have a condition that limits my ability to engage in physical activity.
I have a life expectancy of less than 6 months.
I am currently receiving treatment for cancer that has relapsed.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 mon…
This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Have primary diagnosis of cancer;
2. Are within 1 year of completion of primary therapy OR have a diagnosis of metastatic cancer
1. For the purpose of this study, primary therapy is defined as treatment of curative intent, first-line or later, from which the individual is…
Inclusion Criteria:
1. Have primary diagnosis of cancer;
2. Are within 1 year of completion of primary therapy OR have a diagnosis of metastatic cancer
1. For the purpose of this study, primary therapy is defined as treatment of curative intent, first-line or later, from which the individual is advancing to active surveillance or follow-up with or without maintenance therapy
2. For individuals with metastatic cancer, individuals may be included provided they completed primary therapy for a de novo diagnosis of metastatic disease within the last year, are within one year of completion of initial therapy for their primary cancer diagnosis for which disease progression has occurred, or who are within one year of receiving treatment for metastatic disease (including individuals currently receiving treatment).
3. Are aged 18 years and older;
4. Can read and consent to participate in the trial;
5. Can read and speak English;
6. Can complete study follow-up at pre-specified intervals;
7. Have access to mobile technology (e.g. a smart phone or tablet) that would allow engagement in digital health coaching for the collection of PROs and wearable data.
Exclusion Criteria:
1. Have a cognitive impairment (as assessed by their provider) that would prohibit the individual from engaging with the digital health coaching program or complete study assessments;
2. Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to engage in physical activity (as assessed by their provider)
3. Have a life expectancy of \<6 months, and/or
4. Are on active treatment for relapsed disease. a. Individuals with disease progression or relapse which occurs following their consent to participate will be given the option to continue on study if they wish to do so. Data from individuals experiencing disease progression or relapse will be grouped for sub-analysis to explore if and how relapse impacts study outcomes.
Healthy Volunteers must:
1. Be adults aged 18 years or older or the age of majority in their state of residence, whichever is older.
2. Must reside in the same dwelling as the patient participant
3. Can read and consent to participate in the trial;
4. Can read and speak English;
5. Can complete study follow-up at pre-specified intervals;
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