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Hematopoietic and Lymphoid Cell NeoplasmSALSANCT05075759

Testing Counseling and Mobile Health Interventions to Improve Physical Activity and Diet Quality in Survivors of Childhood Cancer

A study testing Behavioral Intervention, Survey Administration and Interview in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This clinical trial evaluates several behavioral interventions for the improvement of physical activity in cancer patients. Childhood and adolescent/young adult cancer survivors have been reported to have poor diet quality and rarely meet recommended physical activity guidelines. Read more about this study

Who is it for?
Ages 18 to 54 years
What is being tested?
Behavioral Intervention, Survey Administration and Interview
Could I receive a placebo?
No, everyone receives an active treatment
How many people
374 participants
Where
2 sitesUnited States
Study dates
6 Jun 2022to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 54 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Childhood Cancer Survivor Study (CCSS) participant who is between age 18 to < 55 years at time of initial approach
  • Moderate to high CV risk status based on CCSS risk prediction models for cardiomyopathy and ischemic heart disease
  • Able to read, write, and speak English
  • Ability to understand and the willingness to provide informed consent
  • At least one of the following:
  • Less than 30 minutes/day of moderate to vigorous physical activity (MVPA) based on validated self-report instrument (Godin)
Show all 10Show fewer
  • Healthy Eating Index (HEI)-2015 score < 60 per study food frequency questionnaire (FFQ)
  • Body mass index (BMI) >= 25 kg/m^2 per self-reported height and weight
  • Be free of any known (self-reported) ischemic heart disease or cardiomyopathy
  • Have internet access (can be via smartphone or computer; if neither device is available, the study can loan participants a Wi-Fi enabled device, but participant will need to have access to the internet)

Who cannot join

  • Individuals with known cardiomyopathy or ischemic heart disease based on prior CCSS surveys are excluded. While not likely to be common, participants who newly report in our study's screening questionnaire that they have newly diagnosed cardiomyopathy or ischemic heart disease will also be excluded
  • Having any self-reported contraindication to walking or being physically active
  • Not currently known to be pregnant; individuals known to be pregnant and otherwise eligible for the study can be enrolled once no longer known to be pregnant. Participants who report being pregnant after randomization can remain in the study
  • Individuals receiving active cancer treatment. Participants who report starting active cancer treatment after randomization can remain in the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: SALSA: Study of Active LifeStyle Activation

This clinical trial evaluates several behavioral interventions for the improvement of physical activity in cancer patients. Childhood and adolescent/young adult cancer survivors have been reported to have poor diet quality and rarely meet recommended physical activity guidelines. This trial aims to see whether a tailored intervention based on self-determination theory may help to improve physical activity and dietary change.

Read the detailed description

OUTLINE: Patients are randomized to Arms 1, 2, or 3.

ARM 1: Patients receive a personalized clinician-led self-management telehealth session at baseline and 2 months. Patients with poor response at 3 months are randomized to Arm 2 or 4, otherwise patients receive the same telehealth session at months 4 and 6. Patients may receive 2 additional telehealth sessions after 6 months.

ARM 2: Patients receive personalized goal setting for daily steps and activity (updated weekly) and 3 dietary goals (updated monthly) with social media peer support for 6 months. Patients with poor response at 3 months are randomized to Arms 1 or 4. Patients may receive personalized goal setting for daily steps and activity (updated monthly) and dietary goals (updated every 2 months) after 6 months.

ARM 3: Patients receive no intervention for 12 months. After 12 months, they may optionally receive their choice of intervention for up to 6 months.

ARM 4: If Arms 1 or 2 patients have poor response after 3 months, patients may be re-randomized to Arm 4. Patients receive remote sessions with a health coach every 1-2 weeks for 3 months. Patients may continue to receive remote sessions once a month after 3 months, during the maintenance phase (months 6-12).

Being tested
Behavioral Intervention, Survey Administration, Interview
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral InterventionBehavioural

    Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy

    Receive personalized clinician-led self-management telehealth sessions

  • Behavioral InterventionBehavioural

    Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy

    Receive personalized goal setting for daily steps and activity and dietary goals

  • Behavioral InterventionBehavioural

    Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy

    Remote sessions with a health coach

  • Survey AdministrationOther

    Ancillary studies

  • InterviewOther

    Ancillary studies

Study groups in NCT05075759
Study groupRoleWhat they receive
Arm 1 (personalized clinician-led self-management telehealth)ExperimentalPatients receive a personalized clinician-led self-management telehealth session at baseline and 2 months. Patients with poor response at 3 months are randomized to Arm 2 or 4, otherwise patients receive the same telehealth session at months 4 and 6. Patients may receive 2 additional telehealth sessions after 6 months.
Receives: Behavioral: Behavioral Intervention; Other: Survey Administration; Other: Interview
Arm 2 (personalized goal setting)ExperimentalPatients receive personalized goal setting for daily steps and activity (updated weekly) and 3 dietary goals (updated monthly) with social media peer support for 6 months. Patients with poor response at 3 months are randomized to Arms 1 or 4. Patients may receive personalized goal setting for daily steps and activity (updated monthly) and dietary goals (updated monthly) after 6 months.
Receives: Behavioral: Behavioral Intervention; Other: Survey Administration; Other: Interview
Arm 3 (waitlist)Active comparatorPatients receive no intervention for 12 months. After 12 months, they may optionally receive their choice of intervention for up to 6 months.
Receives: Other: Survey Administration; Other: Interview
Arm 4 (remote sessions with a health coach)ExperimentalArm 1 and 2 patients with poor response after 3 months can be re-randomized to Arm 4. Patients receive remote sessions with a health coach every 1-2 weeks for 3 months. Patients may continue to receive remote sessions once a month after 3 months, during the maintenance phase (months 6-12).
Receives: Behavioral: Behavioral Intervention; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sedentary time

    <100 counts/minute as measured by research-grade accelerometry

    Measured: Up to 12 months

  2. Healthy Eating Index (HEI)-2015 score

    On a scale of 100 (perfect score) as measured by Food Frequency Questionnaire

    Measured: Up to 12 months

Secondary outcomes (3)

  1. Participant engagement

    As measured by: 1) response to clinician action plans [score of 0-10; 10 being most engaged]; 2) use of mHealth apps [e.g., number of days with daily steps ≥500; number of days with recorded calories ≥500; social media interactions counting viewing, liking, or posting comments]; and 3) number of sessions completed with lifestyle health coach and coach's rating of engagement [score of 0-10; 10 being most engaged]

    Measured: Up to 12 months

  2. Health-related self-efficacy scale

    Per Schwarzer R, et al. and converted to T-score (higher equaling greater self-efficacy)

    Measured: Up to 12 months

  3. Multidimensional Health Locus of Control Scale

    Per Wallston KA, et al. with 3 subscales: internal, chance, and powerful others (each scored from 6-36, with higher values indicating greater agreement with that subscale's locus on control beliefs)

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2021
  2. Study start6 Jun 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05075759
Sponsor's protocol ID
RG1121690
Other IDs
NCI-2021-09186, 10784, R01CA263144
Acronym
SALSA
Status last verified
Oct 2026
First submitted
13 Sep 2021
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chow E, Lee E, Hershberger M, Jenssen K, Di C, Doody D, Hogue B, Mendoza J, Muller T, Schenk J, Syrjala K, Xu Y, Yi J, Zhao YQ, Armstrong G, Neuhouser M, Oeffinger K. Protocol for a Sequential Multiple Assignment Randomized Trial to Improve Physical Activity and Diet Quality in Survivors of Cancer. JMIR Res Protoc. 2026 Aug 13;15:e104572. doi: 10.2196/104572.

    PubMed 42594273

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Intervention, Survey Administration and Interview in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sedentary time (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05075759, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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