Oral Cancer
Conditions
Keywords
Oral cancer, Trismus, Mouth-opening training, Jaw exercise
Brief summary
PURPOSE:The purpose of the study was to investigate the effect of mouth-opening training with follow-up telephone calls for reducing postoperative trismus in patients with oral cancer. METHODS:The study is a randomized clinical trial using repeated measures. Sixty-eight patients admitted at a general hospital in Taiwan for oral cancer surgery were recruited and randomly assigned to either the intervention or control group. All subjects were instructed to practice mouth-opening exercises three times a day every day for three months. Subjects in the intervention group received additional 6 follow-up phone calls to enhance mouth-opening exercise adherence. Data on maximum interincisal opening and mandibular function impairment were collected before surgery, at one-month, and three-months after discharge, using the TheraBite Range-of-Motion scale and Mandibular Function Impairment Questionnaire.
Detailed description
The purpose of the study was to investigate the effect of mouth-opening exercise training with follow-up telephone calls for preventing postoperative trismus in patients with oral cancer. The specific aims were to test the intervention effects on enhancing mouth-opening exercise practice, MIO, and mandibular function. We hypothesized that the intervention group would show 1) better adherence to mouth-opening exercises, 2) greater MIO, and 3) better mandibular function over time, compared to the control group. The study is a randomized clinical trial using repeated measures. A convenience sample of 68 oral cancer patients was recruited and randomly assigned to either the intervention or control group according to a list generated by the Random Allocation Software. Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence. Data on MIO and mandibular function impairment were collected before surgery, at one-month, and three-months after discharge, using the TheraBite Range-of-Motion scale and the Mandibular Function Impairment Questionnaire. The study was approved by the research ethics committee of the hospital where the data were collected. All statistical analyses were carried out using the SPSS statistical package version 20.0 (SPSS Inc., Chicago, IL, USA). Characteristics of the subjects were summarized by percentages, means, and standard deviations (SDs). Chi-squared tests or Fisher's exact tests and two independent samples t-tests were used to examine group baseline equivalency. Value changes of study outcomes (MIO and mandibular function impairment) and mouth-opening exercises performed from T1, T2, to T3 were expressed in two study groups. A general linear model was used to model these outcomes as a function of main group effect and main time effect. An interaction term (group difference by time) was added into each model to investigate the synergistic effect of the intervention with time. Both the stability analysis and the analysis of repeated relationships were performed by generalized estimation equations (GEE).
Interventions
BEHAVIORALThe mouth-opening training with follow-up telephone calls program
Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
BEHAVIORALThe mouth-opening training without follow-up telephone calls program
Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
Sponsors
Yuan's General Hospital
National Taipei University of Nursing and Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. aged 18 years or older 2. diagnosed with oral cancer 3. scheduled for a primary curative oral cancer surgery 4. able to communicate in Mandarin or Taiwanese 5. obtained medical clearance from the patient's attending physician to participate in the study
Exclusion criteria
1. diagnosed with lip or tongue cancers which were less relevant to trismus 2. had central incisors extracted during the surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TheraBite Range-of-Motion Scale | Change from Baseline to 3 months | The TheraBite® Range-of-Motion Scale was used to measure the maximum incisal opening (MIO), which is the maximal vertical distance between the edges of the incisors of the maxilla and the mandible. The TheraBite® Range-of-Motion Scale is a disposable paper measuring scale specially designed to measure a subject's mouth and jaw opening. The subject sits in an upright position with his mouth open wide. For measuring the vertical opening, the scale has a possible range of 5 to 70 mm, with the notch is placed on the lower incisor midline. The usual range of MIO is between 40 and 55 mm. Subjects with MIO \<35 mm are considered to have trismus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mandibular Function Impairment Questionnaire (MFIQ) | Change from Baseline to 3 months | The MFIQ (Mandibular Function Impairment Questionnaire) was used to measure the extent of patients' mandibular function impairment. The questionnaire consists of 17 items, each of which targets a specific oral function impairment; including difficulties in social activity, speech, taking a large bite, chewing hard food, chewing soft food, work and/or daily activities, drinking, laughing, chewing resistant food, yawning, kissing, and eating different types of food. The subjects were asked to indicate how much difficulty they had with each activity or with eating each type of food using a 5-point Likert scale (0 = no difficulty, 4 = very difficult or impossible without help). The total score of the 17 items divided by 68 provides the scale score, with a possible range of 0 to 1. A higher score indicates greater severity of the mandibular function impairment. A score ≤ 0.3, between 0.3 and 0.6, and \>0.6 indicates mild, moderate, and severe mandibular function impairment, respectively. |
Countries
Taiwan
Participant flow
Recruitment details
Patients admitted to the hospital for curative oral cancer surgeries were recruited from surgical units of are going a teaching hospital in southernTaiwan. Potential subjects were referred by physicians and then screened by one of the researchers to determine their eligibility.
Pre-assignment details
72 people didn't meet inclusion criteria and 6 people decline to the study.
Participants by arm
| Arm | Count |
|---|---|
| Mouth-opening Training With Follow-up Calls Subjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
The mouth-opening training with follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence. | 30 |
| Mouth-opening Training Without Follow-up Calls Subjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
The mouth-opening training without follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Mouth-opening Training With Follow-up Calls | Mouth-opening Training Without Follow-up Calls | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 5 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 25 Participants | 47 Participants |
| Region of Enrollment Taiwan | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 28 Participants | 26 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
TheraBite Range-of-Motion Scale
The TheraBite® Range-of-Motion Scale was used to measure the maximum incisal opening (MIO), which is the maximal vertical distance between the edges of the incisors of the maxilla and the mandible. The TheraBite® Range-of-Motion Scale is a disposable paper measuring scale specially designed to measure a subject's mouth and jaw opening. The subject sits in an upright position with his mouth open wide. For measuring the vertical opening, the scale has a possible range of 5 to 70 mm, with the notch is placed on the lower incisor midline. The usual range of MIO is between 40 and 55 mm. Subjects with MIO \<35 mm are considered to have trismus.
Time frame: Change from Baseline to 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mouth-opening Training With Follow-up Calls | TheraBite Range-of-Motion Scale | Baseline | 27.43 units on a scale | Standard Deviation 10.71 |
| Mouth-opening Training With Follow-up Calls | TheraBite Range-of-Motion Scale | 3 month later | 27.33 units on a scale | Standard Deviation 9.73 |
| Mouth-opening Training Without Follow-up Calls | TheraBite Range-of-Motion Scale | Baseline | 26.57 units on a scale | Standard Deviation 10.53 |
| Mouth-opening Training Without Follow-up Calls | TheraBite Range-of-Motion Scale | 3 month later | 16.17 units on a scale | Standard Deviation 8.01 |
Secondary
Mandibular Function Impairment Questionnaire (MFIQ)
The MFIQ (Mandibular Function Impairment Questionnaire) was used to measure the extent of patients' mandibular function impairment. The questionnaire consists of 17 items, each of which targets a specific oral function impairment; including difficulties in social activity, speech, taking a large bite, chewing hard food, chewing soft food, work and/or daily activities, drinking, laughing, chewing resistant food, yawning, kissing, and eating different types of food. The subjects were asked to indicate how much difficulty they had with each activity or with eating each type of food using a 5-point Likert scale (0 = no difficulty, 4 = very difficult or impossible without help). The total score of the 17 items divided by 68 provides the scale score, with a possible range of 0 to 1. A higher score indicates greater severity of the mandibular function impairment. A score ≤ 0.3, between 0.3 and 0.6, and \>0.6 indicates mild, moderate, and severe mandibular function impairment, respectively.
Time frame: Change from Baseline to 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mouth-opening Training With Follow-up Calls | Mandibular Function Impairment Questionnaire (MFIQ) | Baseline | 0.16 score on a scale | Standard Deviation 0.21 |
| Mouth-opening Training With Follow-up Calls | Mandibular Function Impairment Questionnaire (MFIQ) | 3 month later | 0.18 score on a scale | Standard Deviation 0.23 |
| Mouth-opening Training Without Follow-up Calls | Mandibular Function Impairment Questionnaire (MFIQ) | Baseline | 0.17 score on a scale | Standard Deviation 0.2 |
| Mouth-opening Training Without Follow-up Calls | Mandibular Function Impairment Questionnaire (MFIQ) | 3 month later | 0.55 score on a scale | Standard Deviation 0.3 |