None listed
Conditions
Brief summary
The study is evaluating the effectiveness of structured interventions to improve quality of life in head and neck cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 years or more, and have a diagnosis of head and neck cancer for which you have completed treatment within the past month at one of the participating sites. Trial details: Participants in this trial are randomly (by chance) allocated to one of three groups. Participants in group 1 will receive a written resource, “Facing the future: Living with confidence after treatment for head and neck cancer” in addition to usual care. The 61 page publication was developed by a number of health professionals involved in the treatment of people with head and neck cancer, and contains detailed information and recommendations about coping with issues such as diet and swallowing problems, oral health, fatigue, pain, stress, emotional concerns and communication. Participants in Group 2 will continue to receive usual care and the resource “Facing the future: Living with confidence after treatment for head and neck cancer”. In addition they will meet with an oncology nurse who has undergone specific training in developing a tailored survivorship care plan. The face-to-face meeting will take between 30 and 60 minutes and will focus on issues which are of concern to the patient. For example the care plan might include a graded approach to improving fatigue, or a plan about how to get into a routine to manage oral health. It might include details about how to cope with social interactions and relationship concerns, or fear of eating in public. The care plan will be designed to not just list information – it will be designed to enable participants to work out how to feel more in control of their health, deal with anxiety and give them confidence about when and how to get professional advice as needed. Once the survivorship care plan is complete the patient will receive a written copy so that they can keep working on the issues in it. A copy will also be sent to their General Practitioner so that the GP is familiar with the issues the patient is working on and can provide ongoing assistance as necessary. Participants in Group 3 will continue to receive only the standard care provided at the clinic where they received treatment. Participants will be asked to complete some questionnaires at the start of the study, and 3 and 6 months later in order to assess their quality of life. Feasibility and cost-effectiveness of the two interventions will also be assessed.
Interventions
Participants will be randomly allocated to either Usual Care, or one of two possible interventions.
Arm 1
Information: In addition to usual care, patients will receive a written resource “Facing the future: Living with confidence after treatment for head and neck cancer”. This 61-page publication was developed by a number of health professionals involved in the treatment of people with head and neck cancer, and contains detailed information and recommendations about coping with issues such as
Participants will be randomly allocated to either Usual Care, or one of two possible interventions. Arm 1 Information: In addition to usual care, patients will receive a written resource “Facing the future: Living with confidence after treatment for head and neck cancer”. This 61-page publication was developed by a number of health professionals involved in the treatment of people with head and neck cancer, and contains detailed information and recommendations about coping with issues such as diet and swallowing problems, oral health, fatigue, pain, stress, emotional concerns and communication. The resource has been reviewed by consumers and pilot tested at Royal Brisbane and Women’s Hospital, Herston, Australia. Arm 2 Intervention: As with the Information Arm, patients will continue to receive usual care and the resource “Facing the future: Living with confidence after treatment for head and neck cancer”. However they will also meet with an oncology nurse who has undergone specific training in developing a tailored survivorship care plan. The face-to-face meeting will take between 30 and 60 minutes and will focus on issues which are of concern to the patient. For example the care plan might include a graded approach to improving fatigue, or a plan about how to get into a routine to manage oral health. It might include details about how to cope with social interactions and relationship concerns, or fear of eating in public. The care plan will be designed to not just list information – it will be designed to enable participants to work out how to feel more in control of their health, deal with anxiety and give them confidence about when and how to get professional advice as needed. Once the survivorship care plan is complete the patient will receive a written copy so that they can keep working on the issues in it. A copy will also be sent to their General Practitioner so that the GP is familiar with the issues the patient is working on can provide ongoing assistance as necessary. Oncology nurses who are providing the intervention will undergo focused training which will include completion of a self-directed training manual and a day-long skills development session. During the delivery of the intervention the nurses will also participate in fortnightly clinical supervision, facilitated by study investigators highly experienced in health professional education and skill development.
Sponsors
Associate Professor Jane Turner
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients eligible for this study must have a diagnosis of head and neck cancer and must have undergone treatment at one of the participating sites Inclusion criteria: * Aged 18 years or over * Have within the past month completed a defined treatment protocol for cancer of the tongue, mouth, salivary glands. pharynx, the oro-, hypo- and nasopharynx, nasal cavities, middle ear, sinuses or larynx OR Within the past month have completed a defined treatment protocol for non-melanoma skin cancers of the head and neck requiring treatment known to cause toxicity (for example, combinations of surgery, radiotherapy or chemotherapy). * Able to speak and read English * Physical, cognitive and mental status such that can participate in the study
Exclusion criteria
Exclusion criteria: * Inability to speak and read English * Receiving low-toxicity treatment for head and neck cancer (for example laser therapy alone) * Presence of severe mental, cognitive or physical conditions with would limit the person’s ability to participate in the study, or which require ongoing regular specialist treatment Advanced disease if life expectancy is considered to be less than 6 months
Outcome results
None listed