CancerACCESSNCT02929108
ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision Making)
A study testing Facebook and ACCESS in people with Cancer and Pain, run by Washington University School of Medicine at 3 sites in United States.
Trial summary
The project will test the effect of educating and supporting family caregivers of hospice cancer patients on their active participation in shared decision making in the plan of care for their patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Facebook and ACCESS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 489 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2017to 22 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Is caregiving for a patient enrolled in the participating hospice
- Over 18 years of age
- Is caregiving for a patient with a diagnosis of cancer
- Willing to have a Facebook account and post at least 1x per week if in intervention group
Who cannot join
- No one under the age of 18
- Is caregiving for a patient enrolled in hospice agencies other than those participating in the study
- Unwilling to participate in social media
- Is caregiving for a patient with a diagnosis other than cancer
- Is caregiving for a patient with a life expectancy of less than 2 weeks
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hospice Compassus
Columbia, Missouri, 64503
CrossRoads Hospice
Kansas City, Missouri, 64055
Barnes Jewish Hospice
St Louis, Missouri, 63114
About this study
Official title: ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision)
The project will test the effect of educating and supporting family caregivers of hospice cancer patients on their active participation in shared decision making in the plan of care for their patients.
Read the detailed description
This intervention will target education and emotional support to family caregivers of hospice cancer patients for a shared decision making process in the hospice care plan meetings The intervention ACCESS will consist of three components:
1: a Facebook group to provide the education and support; 2. web conferencing for family members into the hospice interdisciplinary care plan meeting 3, a structured shared decision making process to guide the team discussion.
Participants (family caregivers) will be randomly assigned to one of three groups, usual care, Facebook only, and Access.
The specific aims are to:
- Evaluate the effect of access on family caregiver anxiety, pain knowledge and patient pain.
- Evaluate the effect of Facebook groups as educational emotional support for family caregivers
- Assess staff and family caregiver satisfaction with the shared decision making process.
- Being tested
- Facebook, ACCESS
- Keywords
- hospice, caregiver
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FacebookBehavioural
Participants will be enrolled in a Secret Facebook group for social support and education
ACCESSBehavioural
Intervention will have two components.
- Participants will be enrolled in a Secret Facebook group for social support and education
- Participants will use web conferencing technology to participate in their interdisciplinary team meeting
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | No intervention | The family caregivers in his group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making. |
| Experimental | The family caregivers in this group only participates in the Facebook groups, not in the shared decision making Receives: Behavioral: Facebook | |
| ACCESS | Experimental | The family caregivers in this group participates in Facebook and web conferencing for shared decision making Receives: Behavioral: Facebook; Behavioral: ACCESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Generalized Anxiety Disorder- 7
A screening tool to quantify participant's anxiety. The scale ranges from 0-21. A higher score indicates a higher level of anxiety.
Measured: Upon enrollment, 14 days, 28 days, 60 days and 90 days
Secondary outcomes (8)
Change in Family Pain Questionnaire - Experience
A scale which measures caregiver's experience dealing with patient pain. Scale ranges from 0-70. A higher score indicates higher pain experience.
Measured: Upon enrollment and 28 days
Change in Family Pain Questionnaire - Knowledge
A scale which measures pain knowledge. The scale ranges from 0-90. A higher score indicates a higher knowledge of pain.
Measured: Upon enrollment and 28 days
Change in Caregiver Quality of Life
Four question scale that measures caregivers quality of life. Scale ranges from 0-40. Higher score indicates higher quality of life.
Measured: Upon enrollment, 14 days, 28 days, 60 days and 90 days
Perceived Involvement of Care Scale
A scale measuring perceived involvement of care. Scale ranges from 13-65. Higher score indicates higher perceived involvement in care.
Measured: Upon enrollment, 14 days, 28 days, and 90 days
Public Health Questionnaire (PHQ 9)
A measure of depression. Scale ranges from 0-27. A higher score indicates higher depression.
Measured: Upon enrollment, 14 days, 28 days, 60 days, and 90 days
Edmonton Symptom Assessment
A scale that measures various patient symptoms as reported by caregiver such as pain, fatigue, depression, anxiety, appetite, and nausea. Scale ranges from 0-90. A higher score indicates higher degree of symptoms.
Measured: Upon enrollment, 14 days, 28 days, 60 days, and 90 days
Zarit Burden Scale
A scale that measures the level of burden on caregiver. Scale ranges from 0-28. A higher score indicates greater burden.
Measured: Upon enrollment and 28 days
Caregiver Communication Questionnaire (CCCQ)
A scale that measures the level of perception of caregiver centered communication by hospice staff. Scale ranges from 30-150. A higher score indicates greater perception of caregiver centered communication.
Measured: 14 days, 28 days, and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start1 Apr 2017
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- A pragmatic cluster randomized controlled trial will randomly assign hospice sites (cluster) to 2 of 3 groups: 1) Enhanced usual care 2) Enhanced usual care and private Facebook group 3) Enhanced usual care, private Facebook group, and ACCESS. Each hospice site (cluster) will go through 2 arms of the intervention but the family caregiver participants will only complete one arm.
- Masking
- None (open label)
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Debra Parker Oliver, Washington University School of Medicine
- Investigators
- Debra Oliver, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929108
- Sponsor's protocol ID
- 2006270
- Other IDs
- 5R01CA203999
- Acronym
- ACCESS
- Status last verified
- Mar 2023
- First submitted
- 6 Oct 2016
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parker Oliver D, Demiris G, Washington KT, Pitzer K, Ulrich C. The Effect of Digital Literacy on Participation in Social Media Clinical Trials in Cancer: Tailoring an Informed Consent Process. Telemed J E Health. 2022 Mar 21;28(11):1682-9. doi: 10.1089/tmj.2021.0555. Online ahead of print.
PubMed 35324322Oliver DP, Washington KT, Pitzer K, Popejoy L, White P, Wallace AS, Grimsley A, Demiris G. Mixed methods analysis of hospice staff perceptions and shared decision making practices in hospice. Support Care Cancer. 2022 Mar;30(3):2679-2691. doi: 10.1007/s00520-021-06631-w. Epub 2021 Nov 25.
PubMed 34825279Starr LT, Bullock K, Washington K, Aryal S, Parker Oliver D, Demiris G. Anxiety, Depression, Quality of Life, Caregiver Burden, and Perceptions of Caregiver-Centered Communication among Black and White Hospice Family Caregivers. J Palliat Med. 2022 Apr;25(4):596-605. doi: 10.1089/jpm.2021.0302. Epub 2021 Nov 18.
PubMed 34793244
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision)
- ClinicalTrials.gov ID
- NCT02929108
- Acronym / sponsor ID
- ACCESS / 2006270
- Keywords
- hospice, caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Posted 20 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project will test the effect of educating and supporting family caregivers of hospice cancer patients on their active participation in shared decision making in the plan of care for their patients.
Detailed description
This intervention will target education and emotional support to family caregivers of hospice cancer patients for a shared decision making process in the hospice care plan meetings The intervention ACCESS will consist of three components:
1: a Facebook group to provide the education and support; 2. web conferencing for family members into the hospice interdisciplinary care plan meeting 3, a structured shared decision making process to guide the team discussion.
Participants (family caregivers) will be randomly assigned to one of three groups, usual care, Facebook only, and Access.
The specific aims are to:
- Evaluate the effect of access on family caregiver anxiety, pain knowledge and patient pain.
- Evaluate the effect of Facebook groups as educational emotional support for family caregivers
- Assess staff and family caregiver satisfaction with the shared decision making process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A pragmatic cluster randomized controlled trial will randomly assign hospice sites (cluster) to 2 of 3 groups: 1) Enhanced usual care 2) Enhanced usual care and private Facebook group 3) Enhanced usual care, private Facebook group, and ACCESS. Each hospice site (cluster) will go through 2 arms of the intervention but the family caregiver participants will only complete one arm.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | No intervention | –The family caregivers in his group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making. |
| Experimental | Behavioral: FacebookThe family caregivers in this group only participates in the Facebook groups, not in the shared decision making | |
| ACCESS | Experimental | Behavioral: Facebook, Behavioral: ACCESSThe family caregivers in this group participates in Facebook and web conferencing for shared decision making |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is caregiving for a patient enrolled in the participating hospice
- Over 18 years of age
- Is caregiving for a patient with a diagnosis of cancer
- Willing to have a Facebook account and post at least 1x per week if in intervention group
Key exclusion criteria (5 listed)
- No one under the age of 18
- Is caregiving for a patient enrolled in hospice agencies other than those participating in the study
- Unwilling to participate in social media
- Is caregiving for a patient with a diagnosis other than cancer
- Is caregiving for a patient with a life expectancy of less than 2 weeks
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 |
|---|---|---|
| FacebookParticipants will be enrolled in a Secret Facebook group for social support and education | Behavioural | ACCESS, Facebook |
| ACCESSIntervention will have two components. 1. Participants will be enrolled in a Secret Facebook group for social support and education 2. Participants will use web conferencing technology to participate in their interdisciplinary team meeting | Behavioural | ACCESS |
Primary outcome
Change in Generalized Anxiety Disorder- 7
Time frame: Upon enrollment, 14 days, 28 days, 60 days and 90 days
A screening tool to quantify participant's anxiety. The scale ranges from 0-21. A higher score indicates a higher level of anxiety.
8 secondary outcomes
Change in Family Pain Questionnaire - Experience
Time frame: Upon enrollment and 28 days
Change in Family Pain Questionnaire - Knowledge
Time frame: Upon enrollment and 28 days
Change in Caregiver Quality of Life
Time frame: Upon enrollment, 14 days, 28 days, 60 days and 90 days
Perceived Involvement of Care Scale
Time frame: Upon enrollment, 14 days, 28 days, and 90 days
Public Health Questionnaire (PHQ 9)
Time frame: Upon enrollment, 14 days, 28 days, 60 days, and 90 days
Edmonton Symptom Assessment
Time frame: Upon enrollment, 14 days, 28 days, 60 days, and 90 days
Zarit Burden Scale
Time frame: Upon enrollment and 28 days
Caregiver Communication Questionnaire (CCCQ)
Time frame: 14 days, 28 days, and 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35324322Parker Oliver D, Demiris G, Washington KT, Pitzer K, Ulrich C. The Effect of Digital Literacy on Participation in Social Media Clinical Trials in Cancer: Tailoring an Informed Consent Process. Telemed J E Health. 2022 Mar 21;28(11):1682-9. doi: 10.1089/tmj.2021.0555. Online ahead of print.
- Derived from this study: PubMed 34825279Oliver DP, Washington KT, Pitzer K, Popejoy L, White P, Wallace AS, Grimsley A, Demiris G. Mixed methods analysis of hospice staff perceptions and shared decision making practices in hospice. Support Care Cancer. 2022 Mar;30(3):2679-2691. doi: 10.1007/s00520-021-06631-w. Epub 2021 Nov 25.
- Derived from this study: PubMed 34793244Starr LT, Bullock K, Washington K, Aryal S, Parker Oliver D, Demiris G. Anxiety, Depression, Quality of Life, Caregiver Burden, and Perceptions of Caregiver-Centered Communication among Black and White Hospice Family Caregivers. J Palliat Med. 2022 Apr;25(4):596-605. doi: 10.1089/jpm.2021.0302. Epub 2021 Nov 18.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Debra Oliver, PhD principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facebook and ACCESS in people with Cancer and Pain, run by Washington University School of Medicine 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 4 inclusion and 5 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 20 Apr 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?
Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Generalized Anxiety Disorder- 7 (time frame: Upon enrollment, 14 days, 28 days, 60 days and 90 days). 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 NCT02929108, which also lists 3 linked publications.
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 20 Apr 2023.