Financial ToxicityNCT03676920
Feasibility and Utilization of an Application-based Question Prompt List
A study testing Discussions of Cost App (DISCO App) in people with Financial Toxicity and Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
This trial studies how well an application-based question prompt list works in improving treatment cost discussion between patients with breast, prostate, lung, or colorectal cancer and their oncologists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Financial Toxicity, Cancer, Question Prompt List
- What is being tested?
- Discussions of Cost App (DISCO App)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2018to 31 Dec 2019
- 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
- Medical oncologists or radiation oncologists at KCI McLaren Detroit, McLaren Flint, McLaren Macomb and McLaren Port Huron oncology centers
- Oncologists will be eligible if they treat patients with prostate, breast, lung or colorectal cancers.
- Oncologists will be consented
- Patients must be 18 yrs. old or older
- Patients will be consented
- Patients must be able to read and write in English
- Patients must have a confirmed diagnosis of breast, prostate, lung or colorectal cancer and are scheduled to see an oncologist for an initial treatment discussion.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: Improving Treatment Cost Discussions Between Cancer Patients and Their Oncologists: Feasibility and Utilization of an Application-based Question Prompt List
This trial studies how well an application-based question prompt list works in improving treatment cost discussion between patients with breast, prostate, lung, or colorectal cancer and their oncologists. An application-based question prompt list, called Discussion of Cost Application (DISCO App), may help to improve how patients and oncologists discuss cancer treatment costs.
Read the detailed description
The overall goal of this research is to reduce financial toxicity related to the cost of cancer treatment in a diverse patient population. The research tests the feasibility of an application-based ("app") communication intervention designed to improve the frequency and quality of patient-oncologist treatment cost discussions during clinical interactions, which, in turn, should improve other short- and longer-term patient outcomes, including referrals to economic support (e.g., social work); efficacy in managing treatment cost; treatment cost distress; financial toxicity; and treatment adherence. If successful, this study will result in an evidence-based tool that can reduce financial toxicity and improve medical outcomes for a diverse patient population.
- Conditions
- Financial Toxicity, Cancer, Question Prompt List
- Being tested
- Discussions of Cost App (DISCO App)
- Keywords
- cancer treatment cost, patient-provider communication
- Medical subject headings
- Financial Stress, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discussions of Cost App (DISCO App)Behavioural
Also called DISCO App
The DISCO App is an app-based and patient-focused intervention designed to improve the frequency and quality of patient-oncologist treatment cost discussions. The DISCO App allows patients to provide basic demographic information (e.g., employment status, insurance status, etc), and uses that information to provide patients with an individually-tailored list of treatment cost questions they can ask their provider.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | This feasibility study includes only one arm. All enrolled patients will be asked to use the intervention. Receives: Behavioral: Discussions of Cost App (DISCO App) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-oncologist treatment cost discussions
Observational measures using video-recorded patient-oncologist treatment discussions
Measured: During the treatment discussions and observed via video recordings of those discussions.
Patient-oncologist treatment cost discussions
Self-report measures of if and how patients and oncologists discuss treatment cost.
Measured: Collected immediately after the interaction with the oncologist
Secondary outcomes (6)
Patient financial demographics
Patient financial situation (e.g., income, perceived economic burden, etc.)
Measured: Collected immediately prior to the interaction with the oncologist
Change in patient treatment cost information desired and gained
What cost treatment information patients want before the interaction and if they gained it during the interaction with their oncologist.
Measured: Collected immediately prior to and immediately after the interaction with the oncologist
Change in patient efficacy in managing treatment cost (10-item scale). This measure will assess any change in the patients' efficacy in paying for the cost of their cancer treatment before and after the intervention.
If patients think they will be able to pay for the cost of their cancer treatment. This is adapted from a validated 10-item scale (Peterson AM, Harper FW, Albrecht TL, et al. Parent caregiver self-efficacy and child reactions to pediatric cancer treatment procedures. J Pediatr Oncol Nurs. 2014;31(1):18-27.) An example item is: "I am confident I can pay for the costs of my treatment." Patients will respond to a scale from Strongly Disagree (1) to Strongly Agree (5) with higher values representing a better outcome.
Measured: Collected immediately prior to and immediately after the interaction with the oncologist
Satisfaction with treatment cost discussions (3-item scale). This will assess the extent to which patients are satisfied with any discussions of treatment cost they had with their oncologist.
The extent to which patients are satisfied with any treatment cost discussion they had with their oncologist. This is an investigator-developed 3-item scale. An example item is: "I am satisfied with how my oncologist and I discussed treatment cost today." Patients will respond to a scale from Strongly Disagree (1) to Strongly Agree (5) with higher values representing a better outcome.
Measured: Collected immediately after the interaction with the oncologist
Length of the interaction
Observer measure of the length of the patient-oncologist collected using video recordings.
Measured: During the patient-oncologist interaction and observed via video recordings of the treatment discussions
DISCO App use (observer measure)
Observer measure of how patients use the DISCO App collected using video recordings
Measured: Prior to and during the patient-oncologist interaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start21 Aug 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 Financial ToxicityStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The research tests the feasibility of an application-based ("app") communication intervention designed to improve the frequency and quality of patient-oncologist treatment cost discussions during clinical interactions, and associated measures.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Hamel, Barbara Ann Karmanos Cancer Institute
- Investigators
- Lauren Hamel, Ph.D., Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676920
- Sponsor's protocol ID
- 2017-129
- Status last verified
- Apr 2024
- First submitted
- 12 Sep 2018
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hamel LM, Dougherty DW, Hastert TA, Seymour EK, Kim S, Assad H, Phalore J, Soulliere R, Eggly S. The DISCO App: A pilot test of a multi-level intervention to reduce the financial burden of cancer through improved cost communication. PEC Innov. 2021 Oct 30;1:100002. doi: 10.1016/j.pecinn.2021.100002. eCollection 2022 Dec.
PubMed 37364004
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Treatment Cost Discussions Between Cancer Patients and Their Oncologists: Feasibility and Utilization of an Application-based Question Prompt List
- ClinicalTrials.gov ID
- NCT03676920
- Acronym / sponsor ID
- 2017-129
- Conditions
- Financial Toxicity, Cancer, Question Prompt List
- Keywords
- cancer treatment cost, patient-provider communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Sep 2018 (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.
This trial studies how well an application-based question prompt list works in improving treatment cost discussion between patients with breast, prostate, lung, or colorectal cancer and their oncologists. An application-based question prompt list, called Discussion of Cost Application (DISCO App), may help to improve how patients and oncologists discuss cancer treatment costs.
Detailed description
The overall goal of this research is to reduce financial toxicity related to the cost of cancer treatment in a diverse patient population. The research tests the feasibility of an application-based ("app") communication intervention designed to improve the frequency and quality of patient-oncologist treatment cost discussions during clinical interactions, which, in turn, should improve other short- and longer-term patient outcomes, including referrals to economic support (e.g., social work); efficacy in managing treatment cost; treatment cost distress; financial toxicity; and treatment adherence. If successful, this study will result in an evidence-based tool that can reduce financial toxicity and improve medical outcomes for a diverse patient population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The research tests the feasibility of an application-based ("app") communication intervention designed to improve the frequency and quality of patient-oncologist treatment cost discussions during clinical interactions, and associated measures.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Discussions of Cost App (DISCO App)This feasibility study includes only one arm. All enrolled patients will be asked to use the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Medical oncologists or radiation oncologists at KCI McLaren Detroit, McLaren Flint, McLaren Macomb and McLaren Port Huron oncology centers
- Oncologists will be eligible if they treat patients with prostate, breast, lung or colorectal cancers.
- Oncologists will be consented
- Patients must be 18 yrs. old or older
- Patients will be consented
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Discussions of Cost App (DISCO App)Also: DISCO AppThe DISCO App is an app-based and patient-focused intervention designed to improve the frequency and quality of patient-oncologist treatment cost discussions. The DISCO App allows patients to provide basic demographic information (e.g., employment status, insurance status, etc), and uses that information to provide patients with an individually-tailored list of treatment cost questions they can ask their provider. | Behavioural | Intervention Arm |
Primary outcome
Patient-oncologist treatment cost discussions
Time frame: During the treatment discussions and observed via video recordings of those discussions.
Observational measures using video-recorded patient-oncologist treatment discussions
Patient-oncologist treatment cost discussions
Time frame: Collected immediately after the interaction with the oncologist
Self-report measures of if and how patients and oncologists discuss treatment cost.
6 secondary outcomes
Patient financial demographics
Time frame: Collected immediately prior to the interaction with the oncologist
Change in patient treatment cost information desired and gained
Time frame: Collected immediately prior to and immediately after the interaction with the oncologist
Change in patient efficacy in managing treatment cost (10-item scale). This measure will assess any change in the patients' efficacy in paying for the cost of their cancer treatment before and after the intervention.
Time frame: Collected immediately prior to and immediately after the interaction with the oncologist
Satisfaction with treatment cost discussions (3-item scale). This will assess the extent to which patients are satisfied with any discussions of treatment cost they had with their oncologist.
Time frame: Collected immediately after the interaction with the oncologist
Length of the interaction
Time frame: During the patient-oncologist interaction and observed via video recordings of the treatment discussions
DISCO App use (observer measure)
Time frame: Prior to and during the patient-oncologist interaction
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 Apr 2024.
- Derived from this study: PubMed 37364004Hamel LM, Dougherty DW, Hastert TA, Seymour EK, Kim S, Assad H, Phalore J, Soulliere R, Eggly S. The DISCO App: A pilot test of a multi-level intervention to reduce the financial burden of cancer through improved cost communication. PEC Innov. 2021 Oct 30;1:100002. doi: 10.1016/j.pecinn.2021.100002. eCollection 2022 Dec.
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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.
Lauren Hamel, Ph.D. principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussions of Cost App (DISCO App) in people with Financial Toxicity and Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site 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 7 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Patient-oncologist treatment cost discussions (time frame: During the treatment discussions and observed via video recordings of those discussions.). 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 NCT03676920, 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 Apr 2024.