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Haematological Cancer Web Program Randomised Controlled Trial (RCT)

Improving psychosocial outcomes for haematological cancer patients using a web-based program: A Randomised Controlled Trial (RCT)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000720819
Enrollment
81
Registered
2012-07-05
Start date
2012-11-02
Completion date
2014-10-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Key challenges faced by patients with cancer and their families include coping with a potentially life threatening disease, making decisions about cancer treatment, and managing the side effects of cancer and its treatment. In particular, those diagnosed with haematological cancers may be at high risk for psychosocial distress. Communicating treatment options, the likely impact of treatments, preparing patients for cancer treatments and providing them with information about how to manage side effects of treatment are likely to be key to helping patients and their families cope with a diagnosis of cancer. The purpose of this study is to examine whether an integrated approach (including access to a web-based program and nurse-delivered telephone support) to helping haematological patients with key psychosocial challenges is effective in reducing depression, anxiety, and unmet information needs among patients and their support persons. Participants will be assigned to either a 12-week period of accessing a web-based program designed to provide effective communication, decisional support and adjustment via research staff-provided iPads, or your usual standard of care normally provided by your care team. Who is it for? 10 tertiary referral hospitals that treat at least 15 patients per year will be invited to participate. In order to be eligible for this trial, you will need to be aged 18 years or older; English speaking; newly diagnosed with acute myeloid leukaemia, acute lymphoblastic leukaemia, Burkitt lymphoma, Lymphoblastic lymphoma (B or T cell), Diffuse large b cell lymphoma, potentially making a decision regarding treatment; have a life expectancy of 2 months or more as judged by their clinician; and be able to provide informed consent. This study will also include participation by a sample of support persons, where each patient will be asked to nominate a designated support person. Eligible support persons will be aged 18 or older, able to provide informed consent, and considered by the patient to be an important source of support in relation to the demands of their cancer diagnosis and treatment. Trial Details Consenting eligible patients will be consented into the study by the clinician in their first consultation. Each patient will be given an information statement and consent form to pass onto their nominated support person. Patients and support persons will then be block randomised by week to either the experimental or usual care group. Experimental group: Patients and support persons randomly allocated to the experimental group will be provided with access to a web-based program designed to provide effective communication, decisional support and adjustment. The website provides tailored information on a range of topics including information about diagnosis, treatment options, what is involved in each treatment, side effects, self-management strategies, impact of cancer on day to day life, available support, complementary and alternative therapies. Patients will be able to access the website through iPads provided by the research team. The intervention will also include access to a telephone helpline staffed by an experienced cancer nurse. Usual care: Patients and significant others allocated to the usual care group will receive care normally provided by their care team. Follow-up: Patient and support person follow-up surveys will be completed at approximately 2, 4, 8 and 12 weeks post-recruitment into the study.

Interventions

Patients and support persons randomly allocated to the experimental group will be provided with access to a web-based program designed to provide effective communication, decisional support and adjustment. The website provides tailored information on a range of topics including information about diagnosis, treatment options, what is involved in each treatment, side effects, self-management strategies, impact of cancer on day to day life, available support, complementary and alternative therapies

Patients and support persons randomly allocated to the experimental group will be provided with access to a web-based program designed to provide effective communication, decisional support and adjustment. The website provides tailored information on a range of topics including information about diagnosis, treatment options, what is involved in each treatment, side effects, self-management strategies, impact of cancer on day to day life, available support, complementary and alternative therapies. Patients will be able to access the website at their own discretion using iPads provided by the research team. The intervention will also include access to a telephone helpline staffed by an experienced cancer nurse. Participants will be able to call the helpline during work hours and may leave a voicemail message after hours. The intervention will be available to experimental group participants for a period of 12 weeks.

Sponsors

University of Newcastle
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient sample: Eligible patients will be: aged 18 years or older; English speaking; and newly diagnosed with acute myeloid leukaemia, acute lymphoblastic leukaemia, Burkitt lymphoma, Lymphoblastic lymphoma (B or T cell), Diffuse large B cell lymphoma, potentially making a decision regarding treatment; have a life expectancy of 2 months or more as judged by their clinician; and able to provide informed consent. Support person sample: Eligible support persons will be aged 18 or older, able to provide informed consent, and considered by the patient to be an important source of support in relation to the demands of their cancer diagnosis and treatment. It is very likely that most support persons will be healthy participants however the physical health status of support persons will not be directly assessed and is not the focus of the present research.

Exclusion criteria

Non-English speaking participants, participants under the age of 18, and people with an intellectual or mental impairment have been specifically excluded from the research. Participants under the age of 18 have been excluded as they are unable to give informed consent. While it would be of interest to include non-English speaking participants, they have been excluded due to anticipated difficulties in responding to the written survey and using the website intervention which will be produced in English only. Given informed consent is required as well as completing surveys and accessing web-based information (for the intervention group), people with an intellectual or mental impairment have also been excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 17, 2026