Chemotherapy EffectNCT04331678
Evaluation of a Mobile App to Promote Social Support for Oncology Patients
A study testing Comparator App in people with Chemotherapy Effect, run by West Cancer Center at 3 sites in United States.
Trial summary
Our study will evaluate patient and caregiver use of a new mobile application (app) to support patients undergoing chemotherapy treatment for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Effect
- What is being tested?
- Comparator App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Mar 2020to 24 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Patients must have a confirmed diagnosis of cancer and be prior to or within one month of initiating chemotherapy or immunotherapy
- Have a valid email address
- Have a smart mobile device (Android or iOS) with a data plan
- Willing to download and use the study app
Who cannot join
- Unable to communicate in English.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
West Cancer Center
Germantown, Tennessee, 38138
West Cancer Center
Memphis, Tennessee, 38104
West Cancer Center
Southaven, Mississippi, 38671
About this study
Our study will evaluate patient and caregiver use of a new mobile application (app) to support patients undergoing chemotherapy treatment for cancer.
Read the detailed description
The app is designed to be used by the patient and members of their support network. It provides wide-ranging functionality, including: reminders for appointments and tasks, the ability to track health measures (fitness, emotion, pain, sleep), archive health related documents, maintain notes and recordings from visits, social networking functions to connect with family and friends to coordinate support activities and share news, and educational resources. We will randomize 230 patients initiating chemotherapy cancer treatment and up to one caregiver to the App group (asked to use the app once or more per week) or the Usual Care group, and evaluate the 3-month efficacy of app use on key outcomes.
- Conditions
- Chemotherapy Effect
- Being tested
- Comparator App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator AppBehavioural
Participants will download and agree to use the study app at least once per week during the 3-month intervention period.
The app allows participants to invite a network of friends and family to provide emotional and logistical support during their treatment.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants will be complete survey at enrollment and then again in 3 months. |
| Active | Active comparator | Participants in the App group will receive usual care and complete survey at enrollment and then again in 3 months.
In addition, they will be asked to download the study app to their mobile device and use it at least once per week during the 3-month study period. Receives: Behavioral: Comparator App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
- Investigators will measure the relative changes in functional status of cancer patients using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. FACT-G is a 27-item questionnaire asking participants to report the four primary QoL domains, including physical, social/family, emotional and functional well-being on a 5-point Likert scale where 0 = Not at all to 4 = Very much with higher scores representing better general QoL.
Measured: Baseline, Three months
Change in Short-Form Health Survey (SF-12)
- Investigators will measure differences in quality of life between the two study arms with the SF-12 instrument. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.
Measured: Baseline, Three months
Secondary outcomes (2)
Caregiver's Burden
Changes in the caregiver's burden assessed using the 10-item Caregiver Quality of Life - Cancer Scale (CQOLC) Burden Subscale, where higher scores indicate greater burden.
Measured: Baseline, Three months
Caregiver's Disruptiveness
Changes in the caregiver's disruptiveness of daily life will be assessed using the 7-item CQOLC Disruptiveness Subscale, where scores are calculated as described for burden, and higher scores indicate greater disruptiveness.
Measured: Baseline, Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start12 Mar 2020
- Primary completion24 Oct 2021
- Study completion24 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Emory University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331678
- Sponsor's protocol ID
- 2018-002b
- Status last verified
- Dec 2023
- First submitted
- 31 Mar 2020
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Graetz I, Hu X, Curry AN, Robles A, Vidal GA, Schwartzberg LS. Mobile application to support oncology patients during treatment on patient outcomes: Evidence from a randomized controlled trial. Cancer Med. 2023 Mar;12(5):6190-6199. doi: 10.1002/cam4.5351. Epub 2022 Oct 18.
PubMed 36258654
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mobile App to Promote Social Support for Oncology Patients
- ClinicalTrials.gov ID
- NCT04331678
- Acronym / sponsor ID
- 2018-002b
- Conditions
- Chemotherapy Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- West Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer, Emory University
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 24 Oct 2021 (actual)
- Study completion
- 24 Oct 2021 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study will evaluate patient and caregiver use of a new mobile application (app) to support patients undergoing chemotherapy treatment for cancer.
Detailed description
The app is designed to be used by the patient and members of their support network. It provides wide-ranging functionality, including: reminders for appointments and tasks, the ability to track health measures (fitness, emotion, pain, sleep), archive health related documents, maintain notes and recordings from visits, social networking functions to connect with family and friends to coordinate support activities and share news, and educational resources. We will randomize 230 patients initiating chemotherapy cancer treatment and up to one caregiver to the App group (asked to use the app once or more per week) or the Usual Care group, and evaluate the 3-month efficacy of app use on key outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants will be complete survey at enrollment and then again in 3 months. |
| Active | Active comparator | Behavioral: Comparator AppParticipants in the App group will receive usual care and complete survey at enrollment and then again in 3 months. In addition, they will be asked to download the study app to their mobile device and use it at least once per week during the 3-month study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Patients must have a confirmed diagnosis of cancer and be prior to or within one month of initiating chemotherapy or immunotherapy
- Have a valid email address
- Have a smart mobile device (Android or iOS) with a data plan
- Willing to download and use the study app
Key exclusion criteria (1 listed)
- Unable to communicate in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparator AppParticipants will download and agree to use the study app at least once per week during the 3-month intervention period. The app allows participants to invite a network of friends and family to provide emotional and logistical support during their treatment. | Behavioural | Active |
Primary outcome
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
Time frame: Baseline, Three months
a. Investigators will measure the relative changes in functional status of cancer patients using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. FACT-G is a 27-item questionnaire asking participants to report the four primary QoL domains, including physical, social/family, emotional and functional well-being on a 5-point Likert scale where 0 = Not at all to 4 = Very much with higher scores representing better general QoL.
Change in Short-Form Health Survey (SF-12)
Time frame: Baseline, Three months
a. Investigators will measure differences in quality of life between the two study arms with the SF-12 instrument. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.
2 secondary outcomes
Caregiver's Burden
Time frame: Baseline, Three months
Caregiver's Disruptiveness
Time frame: Baseline, Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 36258654Graetz I, Hu X, Curry AN, Robles A, Vidal GA, Schwartzberg LS. Mobile application to support oncology patients during treatment on patient outcomes: Evidence from a randomized controlled trial. Cancer Med. 2023 Mar;12(5):6190-6199. doi: 10.1002/cam4.5351. Epub 2022 Oct 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparator App in people with Chemotherapy Effect, run by West Cancer Center at 3 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score (time frame: Baseline, Three 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 NCT04331678, 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 18 Dec 2023.